Drugs / Irinotecan
last change 4 days ago re-read 8 days ago

Irinotecan

Small molecule targets TOP1 via inhibition

Developed for
colorectal cancer · gastric cancer · malignant pancreatic neoplasm · small cell lung carcinoma · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · cancer of unknown primary site · esophageal cancer
+258 more · rectal cancer · neuroblastoma · metastasis from malignant tumor of colon · cancer · colorectal carcinoma · gastroesophageal junction adenocarcinoma · glioblastoma · lung cancer · biliary tract cancer · metastatic malignant neoplasm · non-small cell lung carcinoma · colorectal neoplasm · Ewing sarcoma · esophageal squamous cell carcinoma · central nervous system neoplasm · childhood malignant neoplasm · breast cancer · gastric adenocarcinoma · sarcoma · colon carcinoma · neoplasm · rhabdomyosarcoma · rectal carcinoma · metastatic neoplasm · colorectal adenocarcinoma · cholangiocarcinoma · gastric neoplasm · gliosarcoma · malignant glioma · neuroendocrine carcinoma · peritoneal carcinomatosis · rectal signet ring cell adenocarcinoma · rectum mucinous adenocarcinoma · refractory malignant neoplasm · colon mucinous adenocarcinoma · colon signet ring cell adenocarcinoma · gastroesophageal cancer · malignant colon neoplasm · pancreatic exocrine neoplasm · primary peritoneal carcinoma · triple-negative breast carcinoma · colon adenocarcinoma · digestive system cancer · fallopian tube cancer · gallbladder cancer · hepatocellular carcinoma · ovarian cancer · pancreatic neoplasm · small intestine cancer · adenocarcinoma · bile duct cancer · diffuse gastric adenocarcinoma · female breast carcinoma · gastric carcinoma · gastric intestinal type adenocarcinoma · liver cancer · lymphoma · medulloblastoma · osteosarcoma · rectum adenocarcinoma · small intestine adenocarcinoma · carcinoid tumor · diffuse intrinsic pontine glioma · gastroesophageal adenocarcinoma · glioma · head and neck cancer · intrahepatic cholangiocarcinoma · kidney cancer · rectal neoplasm · soft tissue sarcoma · alveolar rhabdomyosarcoma · anaplastic astrocytoma · anaplastic oligodendroglioma · bone cancer · brain cancer · carcinoma of esophagus · central nervous system cancer · cervical cancer · childhood medulloblastoma · digestive system neuroendocrine neoplasm · esophageal adenocarcinoma · ganglioneuroblastoma · hepatoblastoma · HER2 positive breast carcinoma · high grade malignant neoplasm · metastatic malignant neoplasm in the brain · nasopharyngeal carcinoma · neoplasm of esophagus · ovarian carcinoma · pancreas disorder · pancreatic acinar cell carcinoma · urinary bladder cancer · acute lymphoblastic leukemia · adult glioblastoma · ampulla of vater adenocarcinoma · anal carcinoma · appendix cancer · appendix carcinoma · astrocytoma (excluding glioblastoma) · biliary tract neoplasm · brain neoplasm · cervical carcinoma · childhood botryoid rhabdomyosarcoma · childhood cerebral astrocytoma · childhood oligodendroglioma · cutaneous neuroendocrine carcinoma · desmoplastic small round cell tumor · digestive system neoplasm · endocrine gland neoplasm · endometrial cancer · endometrial carcinoma · extrahepatic bile duct carcinoma · gallbladder carcinoma · gastrointestinal stromal tumor · head and neck squamous cell carcinoma · Her2-receptor negative breast cancer · Hodgkins lymphoma · hypopharynx squamous cell carcinoma · kidney Wilms tumor · larynx verrucous carcinoma · leukemia · liver disorder · malignant epithelial tumor of ovary · melanoma · mesothelioma · metastatic malignant neoplasm in the colon · nasal cavity and paranasal sinus squamous cell carcinoma · nasopharyngeal squamous cell carcinoma · neuroendocrine neoplasm · non-Hodgkin lymphoma · oropharynx squamous cell carcinoma · peritoneal carcinoma · peritoneal neoplasm · pineoblastoma · prostate carcinoma · renal cell carcinoma · rhabdoid tumor · small intestine lymphoma · squamous cell carcinoma · urothelial carcinoma · verrucous carcinoma of oral cavity · acinar cell carcinoma · acute leukemia · acute leukemia of ambiguous lineage · adenoid cystic carcinoma · adult hepatocellular carcinoma · adult T-cell leukemia/lymphoma · AIDS-related primary central nervous system lymphoma · ampulla of vater cancer · anaplastic large cell lymphoma · anaplastic oligoastrocytoma · angioimmunoblastic T-cell lymphoma · anus cancer · appendiceal neoplasm · astrocytoma, IDH-mutant, grade 4 · ATM-related cancer predisposition · benign meningioma · bile duct adenocarcinoma · bladder transitional cell carcinoma · borderline epithelial tumor of ovary · botryoid rhabdomyosarcoma · brain oligodendroglioma · BRCA1-related cancer predisposition · BRCA2-related cancer predisposition · breast neoplasm · Burkitt lymphoma · carcinoma · carcinoma of lip · central nervous system non-hodgkin lymphoma · central nervous system primitive neuroectodermal neoplasm · cerebellar astrocytoma · childhood brain stem glioma · childhood central nervous system germ cell tumor · childhood choroid plexus neoplasm · childhood ependymoma · childhood spinal cord tumor · childhood supratentorial embryonal tumor with multilayered rosettes, C19MC-altered · choroid plexus neoplasm · chronic lymphocytic leukemia/small lymphocytic lymphoma · colonic neoplasm · craniopharyngioma · diffuse large B-cell lymphoma · distal biliary tract carcinoma · duodenum cancer · esthesioneuroblastoma · estrogen-receptor negative breast cancer · Ewing sarcoma/peripheral primitive neuroectodermal tumor · exocrine pancreatic carcinoma · gallbladder adenocarcinoma · giant cell glioblastoma · grade II meningioma · grade III meningioma · high grade astrocytic tumor · immunodeficiency-associated lymphoproliferative disease · intrahepatic bile duct cancer · intraocular lymphoma · inverted papilloma · large-cell immunoblastic lymphoma · liver and intrahepatic bile duct neoplasm · low grade glioma · lung carcinoma · lymphoepithelial-like carcinoma · male breast carcinoma · malignant exocrine pancreas neoplasm · malignant neoplasm of thoracic esophagus · malignant tumor of extrahepatic bile duct · MALT lymphoma · mantle cell lymphoma · metastatic carcinoma · metastatic malignant neoplasm in the lymph nodes · metastatic melanoma · metastatic squamous cell carcinoma · mixed cell type kidney Wilms' tumor · mucinous ovarian cancer · mycosis fungoides and variants · nasal cavity and paranasal sinus lethal midline granuloma · neoplastic disease or syndrome · neoplastic syndrome · nervous system disorder · nodal marginal zone B-cell lymphoma · nodular ganglioneuroblastoma · oligodendroglioma · optic pathway glioma · oral cavity mucoepidermoid carcinoma · ovarian clear cell cancer · ovarian germ cell tumor · ovarian sarcoma · ovarian sex cord-stromal tumor · PALB2-related cancer predisposition · pancreatic adenosquamous carcinoma · pancreatic endocrine carcinoma · pancreatic large cell neuroendocrine carcinoma · pancreatic neuroendocrine tumor · pediatric infratentorial ependymoma · pediatric lymphoma · pediatric meningioma · pediatric supratentorial ependymoma · penile cancer · peripheral primitive neuroectodermal tumor · progesterone-receptor negative breast cancer · pseudomyxoma peritonei · renal pelvis/ureter urothelial carcinoma · respiratory system cancer · salivary gland cancer · small intestine leiomyosarcoma · soft tissue neoplasm · spindle cell rhabdomyosarcoma · splenic marginal zone lymphoma · tongue cancer · undifferentiated pancreatic carcinoma · urachus cancer · urethra cancer · urinary tract infection · uterine cervix neoplasm · Wilms tumor · breast carcinoma · malignant germ cell tumor · small cell carcinoma
Investigated by
National Cancer Institute (NCI) · Pfizer · Alliance for Clinical Trials in Oncology · Fudan University · Sun Yat-sen University · Memorial Sloan Kettering Cancer Center
+716 more · Hoffmann-La Roche · Genentech, Inc. · Sanofi · Amgen · Children's Oncology Group · Merck Sharp & Dohme LLC · Federation Francophone de Cancerologie Digestive · Tianjin Medical University Cancer Institute and Hospital · UNICANCER · M.D. Anderson Cancer Center · National Cancer Center, Korea · Roswell Park Cancer Institute · Zhejiang Cancer Hospital · Ipsen · Massachusetts General Hospital · SWOG Cancer Research Network · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Bristol-Myers Squibb · CSPC Ouyi Pharmaceutical Co., Ltd. · Eastern Cooperative Oncology Group · Eli Lilly and Company · GERCOR - Multidisciplinary Oncology Cooperative Group · University of Chicago · AstraZeneca · Duke University · Gruppo Oncologico del Nord-Ovest · Institut du Cancer de Montpellier - Val d'Aurelle · Peking University · St. Jude Children's Research Hospital · H. Lee Moffitt Cancer Center and Research Institute · Roche Pharma AG · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Dana-Farber Cancer Institute · Fox Chase Cancer Center · Fujian Cancer Hospital · Jiangsu HengRui Medicine Co., Ltd. · Liaoning Cancer Hospital & Institute · University Hospital of Crete · Washington University School of Medicine · Asan Medical Center · China Medical University, China · City of Hope Medical Center · Gustave Roussy, Cancer Campus, Grand Paris · National Cheng-Kung University Hospital · Pharmacia and Upjohn · SCRI Development Innovations, LLC · Seoul National University Hospital · Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) · Yale University · Yonsei University · Aventis Pharmaceuticals · Brigham and Women's Hospital · Chinese Academy of Medical Sciences · Jonsson Comprehensive Cancer Center · Merck KGaA, Darmstadt, Germany · Ruijin Hospital · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shanghai Zhongshan Hospital · Taiho Pharmaceutical Co., Ltd. · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · UNC Lineberger Comprehensive Cancer Center · University of California, San Francisco · University of Southern California · Zhejiang University · AIO-Studien-gGmbH · Case Comprehensive Cancer Center · Chang Gung Memorial Hospital · China Medical University Hospital · Eisai Inc. · Hellenic Oncology Research Group · Hokkaido Gastrointestinal Cancer Study Group · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · National Health Research Institutes, Taiwan · National Taiwan University Hospital · all 722 on the full record

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) ONIVYDE — 2024-02-13 fda.gov ↗
Label expansions (3) US (FDA) CAMPTOSAR — 1998-10-22 – 2004-06-24 fda.gov ↗
Approved US (FDA) CAMPTOSAR — 1996-06-14 fda.gov ↗

Trials 1,223 · started per year

today
US approved 1996
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1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 012 trials
Phase 0 NCT07254091 Jan 2026 → Jan 2027 expected malignant pancreatic neoplasm Northwell Health Recruiting No outcome recorded
Phase 0 NCT05238831 Jan 2023 → May 2026 female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 OHSU Knight Cancer Institute Withdrawn No outcome recorded
Phase 0 NCT04135807 Mar 2020 → Jan 2028 expected anaplastic astrocytoma, anaplastic oligodendroglioma, brain oligodendroglioma, glioblastoma Oliver Jonas Recruiting No outcome recorded
Phase 0 NCT03970252 Jul 2019 → May 2024 pancreatic ductal adenocarcinoma Jonsson Comprehensive Cancer Center Completed No outcome recorded
Phase 0 NCT03600623 Sep 2017 → Jul 2020 malignant pancreatic neoplasm, pancreatic exocrine neoplasm University of Alabama at Birmingham Terminated No outcome recorded Stop: Enrollment
Phase 0 NCT03189706 Jun 2017 → Jun 2027 expected neuroblastoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 0 NCT02896907 Oct 2016 → Mar 2018 pancreatic adenocarcinoma Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University Completed No outcome recorded
Phase 0 NCT01992705 Mar 2014 → Sep 2018 pancreatic exocrine neoplasm University of Maryland, Baltimore Completed No outcome recorded
Phase 0 NCT01821612 May 2013 → Nov 2014 pancreatic acinar cell carcinoma, pancreatic ductal adenocarcinoma Alliance for Clinical Trials in Oncology Completed No outcome recorded
Phase 0 NCT01189643 Aug 2010 → Aug 2027 expected desmoplastic small round cell tumor Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 1210 trials
Phase 1 NCT07363408 Dec 2026 → Jul 2027 expected colorectal carcinoma City of Hope Medical Center Not yet recruiting No outcome recorded
Phase 1 NCT07829185 Dec 2026 → Dec 2029 expected pancreatic ductal adenocarcinoma University of Oklahoma Not yet recruiting No outcome recorded
Phase 1 NCT07859085 Oct 2026 → Mar 2029 expected colorectal neoplasm, pancreatic ductal adenocarcinoma Genentech, Inc. Not yet recruiting No outcome recorded
Phase 1 NCT07060014 Sep 2026 → Sep 2028 expected appendix cancer, small intestine cancer The Methodist Hospital Research Institute Recruiting No outcome recorded
Phase 1 NCT07649655 Jul 2026 → Mar 2028 expected colorectal cancer Shanghai EpimAb Biotherapeutics Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT07194044 Feb 2026 → Oct 2030 expected Ewing sarcoma H. Lee Moffitt Cancer Center and Research Institute Recruiting No outcome recorded
Phase 1 NCT06913218 Jul 2025 → Feb 2028 expected pancreatic ductal adenocarcinoma Akeso Not yet recruiting No outcome recorded
Phase 1 NCT05733689 Jun 2025 → Jun 2027 expected gastroesophageal adenocarcinoma University of California, Irvine Recruiting No outcome recorded
Phase 1 NCT06769425 May 2025 → May 2026 overdue female breast carcinoma, gastric cancer, ovarian cancer, prostate cancer +1 Jiangsu Hansoh Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT06835569 Mar 2025 → May 2029 expected colorectal cancer, non-small cell lung carcinoma, pancreatic ductal adenocarcinoma Alterome Therapeutics, Inc. Recruiting No outcome recorded
Show all 210 trials opens the full record — a long page
Phase 1/2106 trials · 3 missed
Phase 1/2 NCT07839819 Nov 2026 → Sep 2029 expected neoplasm PharmaMar Not yet recruiting No outcome recorded
Phase 1/2 NCT07817901 Nov 2026 → Dec 2027 expected metastatic melanoma Yonsei University Not yet recruiting No outcome recorded
Phase 1/2 NCT07853105 Oct 2026 → Feb 2031 expected Ewing sarcoma, bone cancer, osteosarcoma University Hospital, Strasbourg, France Not yet recruiting No outcome recorded
Phase 1/2 NCT07653685 Sep 2026 → Jun 2027 expected colorectal cancer Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1/2 NCT07863869 Sep 2026 → May 2029 expected colorectal cancer Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 1/2 NCT07479732 Mar 2026 → Mar 2027 expected osteosarcoma Peking University People's Hospital Recruiting No outcome recorded
Phase 1/2 NCT07364422 Feb 2026 overdue gastric cancer Onconic Therapeutics Inc. Not yet recruiting No outcome recorded
Phase 1/2 NCT07397819 Nov 2025 → Jun 2028 expected peritoneal neoplasm Dong sheng Zhang Recruiting No outcome recorded
Phase 1/2 NCT07312422 Sep 2025 → Apr 2026 overdue malignant pancreatic neoplasm Zhejiang Provincial People's Hospital Recruiting No outcome recorded
Phase 1/2 NCT05385861 Aug → Dec 2025 overdue digestive system neuroendocrine neoplasm National Health Research Institutes, Taiwan Enrolling by invitation No outcome recorded
Phase 2692 trials · 22 met primary · 27 missed
Phase 2 NCT07841873 Nov 2026 → Jun 2028 expected biliary tract cancer Anhui Provincial Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07258147 Oct 2026 → Dec 2027 expected small cell lung carcinoma Sichuan University Not yet recruiting No outcome recorded
Phase 2 NCT07844057 Oct 2026 → Oct 2029 expected chemotherapy-induced toxicity, metastatic malignant neoplasm, small intestine adenocarcinoma Annika Kurreck Not yet recruiting No outcome recorded
Phase 2 NCT07819019 Oct 2026 → Oct 2028 expected gastric cancer Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center Not yet recruiting No outcome recorded
Phase 2 NCT06890624 Oct 2026 → Oct 2029 expected malignant colon neoplasm Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07802418 Oct 2026 → Jun 2031 expected malignant pancreatic neoplasm Herlev Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07817888 Sep 2026 → Sep 2028 expected — Sixth Affiliated Hospital, Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT07831369 Sep 2026 → Sep 2027 expected astrocytoma, IDH-mutant, grade 4, glioblastoma Inova Health Care Services Recruiting No outcome recorded
Phase 2 NCT07833241 Sep 2026 → Sep 2028 expected pancreatic exocrine neoplasm Shanghai Zhongshan Hospital Not yet recruiting No outcome recorded
Phase 2 NCT07827053 Sep 2026 → Sep 2029 expected pancreatic ductal adenocarcinoma Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Not yet recruiting No outcome recorded
Show all 692 trials opens the full record — a long page
Phase 2/322 trials · 2 met primary · 5 missed
Phase 2/3 NCT06820957 Nov 2025 → Jun 2026 CIC-rearranged sarcoma, Ewing sarcoma, round cell sarcoma with EWSR1-non-ETS fusion, sarcoma with BCOR genetic alterations +1 Children's Oncology Group Terminated No outcome recorded
Phase 2/3 NCT05610163 Dec 2022 → Jul 2030 expected rectum adenocarcinoma Alliance for Clinical Trials in Oncology Active not recruiting No outcome recorded
Phase 2/3 NCT05174169 Jul 2022 → Mar 2029 expected malignant colon neoplasm NRG Oncology Recruiting No outcome recorded
Phase 2/3 NCT05179889 Jul 2021 → Jul 2028 expected malignant colon neoplasm Chungnam National University Hospital Recruiting No outcome recorded
Phase 2/3 NCT04393584 Jan 2019 → Jan 2024 gastric neoplasm Blokhin's Russian Cancer Research Center Unknown No outcome recorded
Phase 2/3 NCT03175016 Jun 2017 → Aug 2019 metastasis from malignant tumor of colon Tianjin Medical University Cancer Institute and Hospital Unknown No outcome recorded
Phase 2/3 NCT03098030 Jun 2017 → Jan 2020 small cell lung carcinoma United Therapeutics Completed Missed primary
Phase 2/3 NCT02758951 Jun 2017 → Oct 2024 overdue colorectal adenocarcinoma, peritoneal carcinoma, peritoneal carcinomatosis Koen Rovers Active not recruiting Missed primary
Phase 2/3 NCT03081143 May 2017 → May 2026 gastroesophageal cancer Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest Completed Missed primary
Phase 2/3 NCT02919787 Sep 2016 → Dec 2022 overdue pancreatic ductal adenocarcinoma Oslo University Hospital Active not recruiting Missed primary
Phase 3139 trials · 20 met primary · 22 missed
Phase 3 NCT07466316 Jun 2026 → Mar 2031 expected rhabdomyosarcoma Children's Oncology Group Not yet recruiting No outcome recorded
Phase 3 NCT06197425 May 2026 → May 2032 expected colorectal adenocarcinoma Centre Hospitalier Universitaire Dijon Recruiting No outcome recorded
Phase 3 NCT07340567 May 2026 → Nov 2032 expected colorectal cancer UNICANCER Not yet recruiting No outcome recorded
Phase 3 NCT07472868 Mar 2026 → Mar 2030 expected rectal carcinoma J. W. A. Burger Not yet recruiting No outcome recorded
Phase 3 NCT07004413 Jan 2026 → Jan 2028 expected colorectal cancer Charite University, Berlin, Germany Not yet recruiting No outcome recorded
Phase 3 NCT07277842 Dec 2025 → Dec 2028 expected rectum adenocarcinoma Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 3 NCT07238283 Dec 2025 → Oct 2028 expected — Jiangsu HengRui Medicine Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT07375563 Nov 2025 → Dec 2026 expected ganglioneuroblastoma, neuroblastoma Federal Research Institute of Pediatric Hematology, Oncology and Immunology Recruiting No outcome recorded
Phase 3 NCT07134205 Oct 2025 → Jun 2027 expected colorectal cancer Shanghai JMT-Bio Inc. Not yet recruiting No outcome recorded
Phase 3 NCT07155629 Sep 2025 → Aug 2030 expected pancreas disorder Helsinki University Central Hospital Not yet recruiting No outcome recorded
Show all 139 trials opens the full record — a long page
Phase 414 trials
Phase 4 NCT07014540 Jun 2025 → Dec 2026 expected neuroendocrine carcinoma Beijing GoBroad Hospital Not yet recruiting No outcome recorded
Phase 4 NCT06951841 Apr 2025 → May 2026 overdue small cell lung carcinoma China Medical University, China Not yet recruiting No outcome recorded
Phase 4 NCT06499610 Jul 2024 → Oct 2027 expected gastric cancer First Affiliated Hospital Xi'an Jiaotong University Not yet recruiting No outcome recorded
Phase 4 NCT06485739 Jul 2024 → Jul 2028 expected neuroendocrine neoplasm First Affiliated Hospital Xi'an Jiaotong University Not yet recruiting No outcome recorded
Phase 4 NCT06467786 Mar 2024 → Sep 2025 overdue small cell lung carcinoma Tang-Du Hospital Recruiting No outcome recorded
Phase 4 NCT05203172 Jul 2022 → Jul 2029 expected cancer Pfizer Recruiting No outcome recorded
Phase 4 NCT05148767 Jan 2022 → Jun 2026 overdue — Zhejiang Cancer Hospital Recruiting No outcome recorded
Phase 4 NCT02348450 Feb 2015 → Feb 2017 small cell lung carcinoma Guangdong Association of Clinical Trials Unknown No outcome recorded
Phase 4 NCT02366819 Dec 2014 → Jun 2026 esophageal adenocarcinoma, gastric adenocarcinoma University of Chicago Suspended No outcome recorded
Phase 4 NCT02401971 Aug 2014 → Aug 2016 gastric cancer Wang Jufeng Unknown No outcome recorded
Phase not applicable28 trials
— NCT06894797 Apr 2025 → Oct 2026 expected — Peking University Cancer Hospital & Institute Recruiting No outcome recorded
— NCT04199026 Feb 2025 → Dec 2028 expected sarcoma M.D. Anderson Cancer Center Recruiting No outcome recorded
— NCT06486545 Aug 2024 → Jul 2025 gastric cancer Hunan Cancer Hospital Unknown No outcome recorded
— NCT06462105 Jul 2024 → Jun 2027 expected small cell lung carcinoma Zhou Chengzhi Not yet recruiting No outcome recorded
— NCT06463548 Jul 2024 → Dec 2025 overdue biliary tract cancer Yunpeng Liu Not yet recruiting No outcome recorded
— NCT06361316 Apr 2024 → Mar 2025 overdue malignant pancreatic neoplasm Kuirong Jiang Recruiting No outcome recorded
— NCT06199232 Jan 2024 → Jun 2026 overdue metastasis from malignant tumor of colon Peking University Active not recruiting No outcome recorded
— NCT06177288 Jan 2024 → Jan 2025 colorectal neoplasm Fudan University Unknown No outcome recorded
— NCT05928312 Aug 2023 → Jun 2025 colorectal cancer Zhejiang Cancer Hospital Unknown No outcome recorded
— NCT05832398 May 2023 → Jan 2025 colorectal cancer Nanfang Hospital, Southern Medical University Unknown No outcome recorded
Comparator or background therapy595 trials
Phase 0 NCT06011772 Background Dec 2023 → Feb 2026 overdue colorectal cancer Roswell Park Cancer Institute Active not recruiting No outcome recorded
Phase 0 NCT03554707 Background Jun 2022 central nervous system cancer SynerGene Therapeutics, Inc. Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT07671339 Background Jun 2026 → Jun 2028 expected pancreatic ductal adenocarcinoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1 NCT07619313 Background Jun 2026 → Jun 2027 expected cholangiocarcinoma, pancreatic ductal adenocarcinoma Jonsson Comprehensive Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT07314385 Background Jan 2026 → Dec 2027 expected pancreatic ductal adenocarcinoma National Taiwan University Hospital Not yet recruiting No outcome recorded
Show all 595 trials opens the full record — a long page

Press releases naming this drug 55 releases

DateIssuerRelease
2025-12-12 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. VOLUNTARY ANNOUNCEMENT - NEW INDICATION FOR DUOENYI (IRINOTECAN HYDROCHLORIDE LIPOSOME INJECTION) OBTAINS MARKETING APPROVAL irasia.com ↗
2025-11-17 PharmaEngine ONIVYDE® with oxaliplatin, fluorouracil and leucovorin will be included in Taiwan NHI for first-line treatment of metastatic pancreatic adenocarcinoma pharmaengine.com ↗
2025-05-31 Ipsen Late-breaking analysis demonstrates characteristics associated with long-term overall survival with Onivyde® regimen in metastatic pancreatic adenocarcinoma ipsen.com ↗
2025-05-15 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. VOLUNTARY ANNOUNCEMENT - EXCLUSIVE LICENSE AGREEMENT WITH CIPLA USA, INC. FOR IRINOTECAN LIPOSOME INJECTION irasia.com ↗
2025-02-05 PharmaEngine PharmaEngine to receive US$50 million in milestone payment as ONIVYDE's 2024 sales in Europe and Asia had reached second milestone pharmaengine.com ↗
2024-06-04 PharmaMar Results presented at ASCO demonstrating the synergy of PharmaMar’s combination of lurbinectedin with irinotecan in patients with relapsed small cell lung cancer pharmamar.com ↗
2024-05-27 Starpharma Pty Ltd Positive final DEP irinotecan Phase 2 clinical trial results starpharma.com ↗
2024-04-25 PharmaMar PharmaMar study of the combination of lurbinectedin and irinotecan on Small Cell Lung Cancer has been selected for a presentation at ASCO pharmamar.com ↗
2024-03-24 PharmaEngine ONIVYDE® obtains positive opinion from EMA's CHMP for new regimen in First-line Treatment of Metastatic PDAC pharmaengine.com ↗
2024-03-18 PharmaEngine ONIVYDE® obtains TFDA Approval for the new regimen in First-line Treatment of Metastatic PDAC pharmaengine.com ↗
2024-02-14 PharmaEngine ONIVYDE® obtains U.S. FDA approval of its supplemental new drug application pharmaengine.com ↗
2024-02-13 Ipsen Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA ipsen.com ↗

Evidence & citations 50 cited values

Every value below carries the sentence it was read from. 1,844 sources stand behind the page.

FieldValueCited text
Known as irinotecan “Patients with colorectal adenocarcinoma (CRC) received a single administration of 0.6 milligrams (mg) / kilograms (kg) of BI 905711 intravenously on Day 3 of each 14-day cycle....” NCT05087992 ↗
1695

“Cetuximab 500mg/m² + envafolimab 200mg + irinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2400 mg/m² civ. 46h all on day 1 of each 2 weeks cycle up to...” NCT05959356 ↗

“Irinotecan will be administered intravenously at a dose of 180 mg/m\^2 along with folinic acid administration intravenously at a dose of 400 mg/m\^2 (racemic) or 200 mg/m\^2...” NCT00778830 ↗

“Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations: * Carboplatin; * Irinotecan; * Etoposide; *...” NCT03632135 ↗

“Patients were randomly assigned (1:1; block size of three), without stratification, to receive FOLFIRI (irinotecan 180 mg/m2, calcium folinate 400 mg/m2 or levofolinate 200...” PMID 36739879 ↗ Feb 2023

“Second-line standard systemic therapies in cohort B include: FOLFOX/XELOX+ bevacizumab, FOLFOX/XELOX+cetuximab (KRAS/NRAS/BRAF WT),...” NCT06841159 ↗

“It will comprise irinotecan, 180 mg/m2 IV infusion over 30 to 120 minutes; leucovorin, 400 mg/m2 IV infusion to match the duration of the irinotecan infusion; and 5-FU, 400...” NCT01124630 ↗

“mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes,...” NCT03099265 ↗

“The FOLFOXIRI chemotherapy regimen (5-fluorouracil, leucovorin, oxaliplatin, irinotecan) will be administered according to the study protocol as part of total neoadjuvant...” NCT07277842 ↗

“Modified FOLFIRINOX: Oxaliplatin 85 mg/m2 intravenous infusion on day 1; Irinotecan 180 mg/m2 intravenous infusion on day 1; 5-Fluorouracil 2400 mg/m2 continuous intravenous...” NCT01446458 ↗

“Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV...” NCT04084496 ↗

Show 1,685 more sources

Known as Aili “Irinotecan monotherapy (trade name: Aili; batches 180103AG” NCT02030678 ↗
Known as BAX2398 “BAX2398 (a liposomal formulation of irinotecan) in combination with 5-FU/calcium levofolinate” NCT02697058 ↗
Known as Campto “A Multicenter Randomized Phase II Study Evaluating The Activity And Tolerability Of Three Different Combinations Of Docetaxel (Taxotere) And Irinotecan (Campto) As Second Line...” NCT00139711 ↗
12

“A Phase 2 Study of the Efficacy and Safety of Irinotecan (Campto®) in Combination With Capecitabine (Xeloda®) as First-Line Chemotherapy in Asian Subjects With Inoperable...” NCT00635323 ↗

“Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started.” NCT01526135 ↗

“Irinotecan (Campto®): 180 mg/m² on D1 by IV infusion in 250 mL of 0.9% saline over 90 minutes.” NCT00467142 ↗

“Irinotecan Hydrochloride Injection(CAMPTO®) pharmacokinetics comparative study” NCT04088604 ↗

“180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes” NCT00561470 ↗

“irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes” NCT02967289 ↗

“Nexavar (Sorafenib) and irinotecan (Campto)” NCT00989469 ↗

“Irinotecan = Camptosar, Campto, or CPT-11” NCT00996346 ↗

NCT00209651 ↗

NCT01022918 ↗

Show 2 more sources

Known as Camptosar “The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as...” NCT00037180 ↗
20

“irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous...” NCT05004350 ↗

“PURPOSE: To determine the activity, toxicity, and pharmacokinetics of irinotecan (CPT-11, Camptosar; Pharmacia & Upjohn, Kalamazoo, MI) in the treatment of adults with...” PMID 10334539 ↗ May 1999

“Phase II Study of Bevacizumab Plus Irinotecan (Camptosar™) in Children With Recurrent, Progressive, or Refractory Malignant Gliomas, Diffuse/Intrinsic Brain Stem Gliomas,...” NCT00381797 ↗

“A Phase I Study of ZD1839 (Iressa) in Combination With Irinotecan (Camptosar or CPT-11) and Vincristine in Pediatric Patients With Refractory Solid Tumors” NCT00186979 ↗

“A Phase II Study Of Irinotecan (Camptosar) And Paclitaxel (Taxol) In Patients With Adenocarcinoma Of The Upper Gastrointestinal Tract” NCT00020761 ↗

“Folinic acid at 400 mg/m2 given as a 90-min infusion immediately after oxaliplatin, and concurrently with irinotecan (Camptosar).” NCT03374852 ↗

“Phase II Study for the Evaluation of CPT-11 (Irinotecan, Camptosar) in Patients With Metastatic or Recurrent Breast Cancer” NCT00004182 ↗

“irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating.” NCT06047379 ↗

“180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes” NCT00561470 ↗

“Irinotecan Injection [Camptosar] (CPT-11) 180 mg/m2, day 1” NCT01523431 ↗

Show 10 more sources

Known as Camptothecin-11 “irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous...” NCT05004350 ↗
Known as CPT-11 “PURPOSE: The aims of this trial were to assess the safety and efficacy of two different dosing schedules of irinotecan (CPT-11) in recurrent glioma patients, to assess...” PMID 19066728 ↗ Dec 2008
76

“The standard and approved treatment for patients with metastatic colorectal cancer is repeated cycles of chemotherapy consisting of a combination of irinotecan (also known as...” NCT00037180 ↗

“irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous...” NCT05004350 ↗

“We hypothesized that germline polymorphisms within genes related to drug target (thymidylate synthase) or metabolizing enzymes (UDP-glucuronosyltransferase, UGT) would impact...” PMID 15709193 ↗ Feb 2005

“This is a phase II study of taxotere, cisplatin and irinotecan (CPT-11) used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects...” NCT00165464 ↗

“A Phase I/II Study to Evaluate Safety and Efficacy in Patients Who Have Resectable Esophageal Cancer and Are Treated With Neoadjuvant Cisplatin, Irinotecan (CPT-11) ZD1839...” NCT00290719 ↗

“PURPOSE: To determine the activity, toxicity, and pharmacokinetics of irinotecan (CPT-11, Camptosar; Pharmacia & Upjohn, Kalamazoo, MI) in the treatment of adults with...” PMID 10334539 ↗ May 1999

“We had previously demonstrated that low dose irinotecan (CPT-11) leads to increased accumulation of cells in S-phase and shows a therapeutic synergy with S-phase specific...” PMID 18594219 ↗ Aug 2008

“Significant activity (radiographic response rates of approximately 60%) has recently been demonstrated in phase II studies in patients with relapsed GBM from the combined use...” NCT00817284 ↗

“Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC# 616348) Plus Fluorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection for...” NCT00003835 ↗

“nal-IRI (nanoliposomal irinotecan, also known as MM-398 and PEP02) is irinotecan free base, (also known as CPT-11) a topoisomerase 1 inhibitor, encapsulated in a liposome drug...” NCT03328884 ↗

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Known as CPT-11:Irinotecan “CPT-11:Irinotecan” NCT01424709 ↗
Known as HE072 “This study (NCT04728035) aimed to explore the safety and efficacy of liposomal irinotecan (HE072) in patients with metastatic triple-negative breast cancer (mTNBC).” PMID 39746964 ↗ Jan 2025
Known as HR070803 “This randomized, double-blind, parallel-controlled, multicenter phase 3 study (NCT05074589) assessed the efficacy and safety of liposomal irinotecan HR070803 combined with...” PMID 39300077 ↗ Sep 2024
1

“Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study.” PMID 39037543 ↗ Jul 2024

Known as IRI “the aim of the present NEXIRI-2/PRODIGE 27 trial was to assess the 2-month non-progression rate for sorafenib (NEX) plus irinotecan (IRI), that is, NEXIRI, treatment.” PMID 32737004 ↗ May 2020
9

“FOLFIRI (folinic acid \[FOL, leucovorin\], fluorouracil \[F, 5-FU\], and irinotecan \[IRI\]) was supplied as solutions for intravenous administration.” NCT00959647 ↗

“FOLFIRI is combination of folinic acid (FOL)/leucovorin, 5-fluorouracil and irinotecan (IRI) which acts as systemic cytotoxic agent.” NCT03250832 ↗

“Patients are planned to receive the SIRIOX regimen including Irinotecan (IRI, 180mg/m2; day 1,day 15) of every cycle” NCT03403101 ↗

“Leucovorin calcium (folinic acid)(FOL) + fluorouracil \[F\] + irinotecan \[IRI\]” NCT00551213 ↗

“bevacizumab (BEV)/irinotecan (IRI) compared with standard temozolomide” PMID 29121274 ↗ Jun 2018

“Irinotecan (IRI) - Starting dose 180 mg/m2” NCT02726334 ↗

“Irinotecan (IRI):135 mg/sq.m (d.i.v.) D1;” NCT04160416 ↗

“Irinotecan (IRI):135 mg/sq.m (d.i.v.) D1” NCT04508452 ↗

“irinotecan (Iri) at progression” PMID 34507244 ↗ Sep 2021

Known as Irinotecan (campto, CPT-11) “Irinotecan (campto, CPT-11)” NCT00166881 ↗
Known as Irinotecan (Camptosar) “Irinotecan (Camptosar)” NCT02178709 ↗
3

“Irinotecan (Camptosar)” NCT00856830 ↗

“Irinotecan, Camptosar®” NCT00003950 ↗

“Irinotecan (Camptosar)” NCT02568046 ↗

Known as Irinotecan (CPT-11) “Irinotecan (CPT-11)” NCT02624726 ↗
Known as Irinotecan (irinotecan HCl, CPT-11 or Campto, Aventis) “Irinotecan (irinotecan HCl, CPT-11 or Campto®, Aventis)” NCT00153998 ↗
Known as Irinotecan - Camptosar - CPT11 “Irinotecan - Camptosar - CPT11” NCT00616005 ↗
1

“Irinotecan-Camptosar-CPT 11” NCT00612638 ↗

Known as Irinotecan Cell pharm “Irinotecan (Irinotecan Cell pharm®)” NCT02085148 ↗
Known as Irinotecan HCl “A Phase I Study to Evaluate Orally Administered Irinotecan HCL (CPT-11) Given as a Powder-Filled Capsule Formulation Daily for 14 Days Every Three Weeks in Patients With...” NCT00004051 ↗
1

“Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1\~Day5” NCT01463982 ↗

Known as irinotecan hydrochloride “OBJECTIVES: I. To define the maximally tolerated dose of the combination of CPT-11 (irinotecan hydrochloride), oxaliplatin, and capecitabine in three different populations,...” NCT00074321 ↗
185

“To evaluate the objective response rate systemically and in the CNS to the combination of irinotecan hydrochloride and temozolomide among patients with breast cancer and...” NCT00617539 ↗

“This phase II trial studies how well giving irinotecan hydrochloride together with oxaliplatin and capecitabine works as first-line therapy in treating patients with metastatic...” NCT00433550 ↗

“Patients receive mFOLFIRINOX comprising oxaliplatin intravenously (IV) over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and...” NCT02047474 ↗

“Irinotecan hydrochloride injection inhibits topoisomerase-I via its active metabolite SN-38, prevents religation of DNA single-strand breaks, causes irreversible DNA...” NCT07653685 ↗

“Patients received modified FOLFIRINOX treatment (85 mg/m2 of oxaliplatin, 180 mg/m2 of irinotecan hydrochloride, 400 mg/m2 of leucovorin calcium, and then 2400 mg/m2 of...” PMID 27275632 ↗ Aug 2016

“This phase II trial studies the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic...” NCT00871169 ↗

“Patients receive irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 (FOLFIRI).” NCT00537121 ↗

“Patients receive bevacizumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.” NCT00628810 ↗

“To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors.” NCT00731276 ↗

“To evaluate the safety and efficacy of irinotecan (irinotecan hydrochloride) in breast cancer patients with brain metastases who progressed after radiation therapy.” NCT01939483 ↗

Show 175 more sources

Known as Irinotecan hydrochloride hydrate ClinicalTrials.gov intervention name — accepted as the source's own label NCT02497157 ↗
Known as Irinotecan Hydrochloride Liposome Injection “Irinotecan hydrochloride liposome Injection 80 mg/m² intravenously Days 1 q2wk” NCT06128837 ↗
2

“Irinotecan hydrochloride liposome injection: 70mg/m2, intravenous infusion” NCT06467786 ↗

“Drug: Irinotecan Hydrochloride Liposome Injection” NCT06499610 ↗

Known as Irinotecan hydrochloride trihydrate “Irinotecan hydrochloride trihydrate is...” NCT04390399 ↗
2

“Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in eluting-beads and injected in the tumor.” NCT03175016 ↗

“Drug: Irinotecan hydrochloride trihydrate” NCT00160875 ↗

Known as Irinotecan hydrochloride: CPT-11 “Irinotecan hydrochloride: CPT-11” NCT00546130 ↗
Known as Irinotecan liposoma “Drug: Irinotecan liposoma” NCT06782685 ↗
Known as Irinotecan Liposomal “Drug: Irinotecan Liposomal” NCT06782685 ↗