Drugs / Rucaparib
last change Mar 2026 re-read 9 days ago

Rucaparib

Small molecule targets PARP1 via inhibition

Developed for
fallopian tube cancer · cancer · neoplasm · ovarian cancer · breast cancer · castration-resistant prostate carcinoma · peritoneum cancer · malignant epithelial tumor of ovary
+42 more · primary peritoneal carcinoma · prostate cancer · endometrial cancer · fallopian tube carcinoma · biliary tract cancer · cervical cancer · esophageal adenocarcinoma · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma · metastatic prostate carcinoma · ovarian carcinoma · prostate adenocarcinoma · small cell lung carcinoma · urothelial carcinoma · carcinosarcoma of the corpus uteri · colorectal carcinoma · diabetes mellitus · diabetic retinopathy · endometrial serous adenocarcinoma · endometrioid adenocarcinoma · female reproductive organ cancer · female reproductive system neoplasm · gastric cancer · leiomyosarcoma · lung adenocarcinoma · lung large cell carcinoma · malignant mesothelioma · malignant pancreatic neoplasm · non-small cell lung carcinoma · non-small cell squamous lung carcinoma · ovarian neoplasm · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · peritoneal carcinoma · prostate carcinoma · renal pelvis carcinoma · serous adenocarcinoma · triple-negative breast carcinoma · ureter carcinoma · urethra cancer · urinary bladder carcinoma · uterine carcinosarcoma
Investigated by
Clovis Oncology, Inc. · pharmaand GmbH · Bristol-Myers Squibb · Foundation Medicine · National Cancer Institute (NCI) · Eli Lilly and Company
+72 more · Hoffmann-La Roche · Merck Sharp & Dohme LLC · AstraZeneca · Bayer · Dana-Farber Cancer Institute · GlaxoSmithKline · Memorial Sloan Kettering Cancer Center · Myriad Genetics, Inc. · North Eastern German Society of Gynaecological Oncology · Novartis · Pfizer · Roche Pharma AG · University of Michigan Rogel Cancer Center · Abramson Cancer Center at Penn Medicine · Academic and Community Cancer Research United · Alliance for Clinical Trials in Oncology · Amgen · Astellas Pharma Inc · Belgian Gynaecological Oncology Group · BerGenBio ASA · Boehringer Ingelheim · British Lung Foundation · Brown University · Cancer Research UK · Central and Eastern European Oncology Group · Clovis Oncology - Pharma and · Dutch Cancer Society · Eisai Inc. · European Network of Gynaecological Oncological Trial Groups (ENGOT) · Exelixis · Fondation ARC · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · GCP-enhederne · GSO Global Clinical Research BV · Genentech, Inc. · Gilead Sciences · Gustave Roussy, Cancer Campus, Grand Paris · Gynecologic Oncology Group · ImmunoGen, Inc. · Incyte Corporation · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Institute of Cancer Research, United Kingdom · Ipsen · Istituto Di Ricerche Farmacologiche Mario Negri · Janssen Pharmaceuticals · Janssen, LP · MedImmune LLC · Medical College of Wisconsin · Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Ohio State University Comprehensive Cancer Center · PGOG (Polish Gynaecologic Oncology Group) · Pamela Munster · Princess Margaret Hospital, Canada · Rhode Island Hospital · Royal Marsden NHS Foundation Trust · SWOG Cancer Research Network · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Stelvio for Life · The Christie NHS Foundation Trust · The Miriam Hospital · The Netherlands Cancer Institute · UNICANCER · University Hospitals, Leicester · University of Arizona · University of Chicago · University of Kansas Medical Center · University of Leicester · University of Oklahoma · University of Utah · University of Washington · Vanderbilt University Medical Center · Zhonglin Hao

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Rubraca — 2018-05-23 europa.eu ↗

Trials 58

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03911453 Apr 2019 → Jul 2021 breast cancer University of Arizona Completed No outcome recorded
Phase 112 trials
Phase 1 NCT04179396 Dec 2019 → Nov 2021 castration-resistant prostate carcinoma pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03840200 Jun 2019 → Dec 2021 breast cancer, ovarian cancer, prostate cancer Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT03954366 Apr → Dec 2019 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03552471 Jul 2018 → Jun 2022 BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, carcinosarcoma of the corpus uteri, endometrial serous adenocarcinoma +3 Ohio State University Comprehensive Cancer Center Completed No outcome recorded
Phase 1 NCT03542175 May 2018 → Jul 2024 breast cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT03521037 Feb 2018 → Sep 2019 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03499444 Feb 2018 → Jun 2019 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03318445 Jan 2018 → Mar 2021 cancer Pamela Munster Completed No outcome recorded
Phase 1 NCT03101280 Apr 2017 → Aug 2020 female reproductive system neoplasm Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT02986100 Nov 2016 → Dec 2017 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT03462212 Mar 2021 → Mar 2025 female reproductive organ cancer Fondazione Policlinico Universitario Agostino Gemelli IRCCS Unknown No outcome recorded
Phase 1/2 NCT04209595 Apr 2020 → Aug 2021 small cell lung carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT04253262 Apr 2020 → Jan 2027 expected prostate carcinoma Brown University Active not recruiting No outcome recorded
Phase 1/2 NCT03995017 Jan 2020 → Oct 2022 esophageal adenocarcinoma, gastric adenocarcinoma University of Kansas Medical Center Unknown No outcome recorded
Phase 1/2 NCT03992131 Jun 2019 → Mar 2022 ovarian cancer, triple-negative breast carcinoma, urothelial carcinoma pharmaand GmbH Terminated No outcome recorded
Phase 1/2 NCT03559049 Dec 2018 → May 2025 non-small cell lung carcinoma University of Michigan Rogel Cancer Center Terminated No outcome recorded Stop: Business
Phase 1/2 NCT03337087 Nov 2018 → Mar 2021 biliary tract cancer, colorectal carcinoma, gastroesophageal junction adenocarcinoma, pancreatic adenocarcinoma Academic and Community Cancer Research United Unknown No outcome recorded
Phase 1/2 NCT03572478 Aug 2018 → Feb 2020 endometrial cancer, prostate cancer University of Chicago Terminated No outcome recorded
Phase 1/2 NCT01482715 Nov 2011 → Mar 2019 fallopian tube cancer, ovarian cancer, peritoneum cancer pharmaand GmbH Completed No outcome recorded
Phase 228 trials · 2 met primary · 1 missed
Phase 2 NCT04624178 Nov 2020 → Nov 2025 overdue leiomyosarcoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04171700 Jan 2020 → Jun 2022 neoplasm pharmaand GmbH Terminated No outcome recorded
Phase 2 NCT03795272 Oct 2019 cervical cancer Nordic Society of Gynaecological Oncology - Clinical Trials Unit Withdrawn No outcome recorded Stop: Business
Phase 2 NCT03958045 Sep 2019 → Nov 2022 small cell lung carcinoma Zhonglin Hao Completed No outcome recorded
Phase 2 NCT03824704 Aug 2019 → Aug 2020 endometrioid adenocarcinoma, fallopian tube carcinoma, ovarian neoplasm, primary peritoneal carcinoma +1 pharmaand GmbH Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03899155 Aug 2019 → Aug 2029 expected cancer Bristol-Myers Squibb Recruiting No outcome recorded
Phase 2 NCT03694262 Jul 2019 → Mar 2023 endometrial cancer, uterine carcinosarcoma Medical College of Wisconsin Completed No outcome recorded
Phase 2 NCT03533946 May 2019 → Jan 2023 prostate cancer University of Utah Terminated No outcome recorded
Phase 2 NCT03845296 Apr 2019 → Jan 2022 BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, lung adenocarcinoma, lung large cell carcinoma +1 SWOG Cancer Research Network Completed No outcome recorded
Phase 2 NCT04276376 Apr 2019 → Jan 2023 cancer Gustave Roussy, Cancer Campus, Grand Paris Terminated No outcome recorded
Phase 38 trials · 3 met primary
Phase 3 NCT04455750 Oct 2021 → Mar 2027 expected castration-resistant prostate carcinoma, prostate adenocarcinoma Alliance for Clinical Trials in Oncology Active not recruiting No outcome recorded
Phase 3 NCT04676334 Mar 2021 → Mar 2023 castration-resistant prostate carcinoma, fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer pharmaand GmbH Completed No outcome recorded
Phase 3 NCT04227522 Jun 2020 → Dec 2023 fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma North Eastern German Society of Gynaecological Oncology Completed No outcome recorded
Phase 3 NCT03768063 Feb 2019 → Jul 2028 expected cancer Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 3 NCT03522246 May 2018 → May 2024 overdue fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma pharmaand GmbH Active not recruiting Mixed
Phase 3 NCT02975934 Jun 2017 → Aug 2022 castration-resistant prostate carcinoma pharmaand GmbH Completed Met primary
Phase 3 NCT02855944 Mar 2017 → Dec 2020 fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer pharmaand GmbH Completed Met primary
Phase 3 NCT01968213 Apr 2014 → Apr 2017 fallopian tube cancer, ovarian cancer, peritoneum cancer pharmaand GmbH Completed Met primary
Comparator or background therapy4 trials
Phase 1/2 NCT04826198 Background Oct 2020 → Apr 2024 ovarian cancer Gustave Roussy, Cancer Campus, Grand Paris Terminated No outcome recorded
Phase 1/2 NCT02711137 Background May 2016 → Feb 2019 cancer Incyte Corporation Terminated No outcome recorded
Phase 2 NCT03617679 Comparator Mar 2019 → Oct 2023 endometrial cancer University of Colorado, Denver Completed No outcome recorded
Phase 2 NCT01074970 Comparator Feb 2010 → Dec 2018 breast cancer Hoosier Cancer Research Network Completed No outcome recorded

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 63 sources stand behind the page.

FieldValueCited text
Known as Rucaparib ClinicalTrials.gov intervention name — accepted as the source's own label NCT03840200 ↗
59

NCT03101280 ↗

NCT00664781 ↗

NCT03768063 ↗

NCT03413995 ↗

NCT03954366 ↗

NCT03338790 ↗

NCT04455750 ↗

NCT04276376 ↗

NCT03654833 ↗

NCT03911453 ↗

Show 49 more sources

Known as AG-014699 “A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In...” NCT01009190 ↗
2

“rucaparib (CO-338; formally AG-014699 or PF-01367338)” NCT00664781 ↗

NCT00457470 ↗

Known as AG-14447 ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055 ↗
Known as AG-14699 ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055 ↗
Known as C0-338 ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055 ↗
Known as CO-338 “The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the experimental study drug rucaparib (also...” NCT03140670 ↗
1

“rucaparib (CO-338; formally AG-014699 or PF-01367338)” NCT00664781 ↗

Known as PF-01367338 “rucaparib (CO-338; formally AG-014699 or PF-01367338)” NCT00664781 ↗
1

NCT01009190 ↗

Known as PF-0136738 “Rucaparib(CO-338;Formally Called AG-014699 or PF-0136738) in Treating Patients With Locally Advanced or Metastatic Breast Cancer or Advanced Ovarian Cancer” NCT00664781 ↗
Known as PF-1367338-BW ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055 ↗
Known as Rubraca ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055 ↗
Known as Rucaparib camsylate “To compare radiographic progression-free survival (rPFS) and overall survival (OS) with enzalutamide and rucaparib camsylate (rucaparib) versus enzalutamide alone for patients...” NCT04455750 ↗
2

“This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and rucaparib camsylate in treating participants with endometrial, ovarian, fallopian...” NCT03552471 ↗

“Drug: Rucaparib camsylate” NCT03521037 ↗

Known as RUCAPARIB PHOSPHATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055 ↗
Action Inhibit “PARP-1 inhibitor” NCT00664781 ↗
Modality Small molecule “Rucaparib is an orally available, small molecule inhibitor” NCT01891344 ↗
Route Intravenous “The study was originally set up with an IV formulation.” NCT00664781 ↗
Target PARP1 “PARP-1 inhibitor” NCT00664781 ↗