Drugs / Dactinomycin
last change Aug 2026 re-read 2 minutes ago

Dactinomycin

Protein / enzyme biologic

Developed for
sarcoma · rhabdomyosarcoma · gestational trophoblastic neoplasm · alveolar rhabdomyosarcoma · kidney cancer · childhood botryoid rhabdomyosarcoma · kidney Wilms tumor · spindle cell rhabdomyosarcoma
+31 more · botryoid rhabdomyosarcoma · choriocarcinoma · hydatidiform mole · ovarian cancer · pleuropulmonary blastoma · rhabdoid tumor of the kidney · adult kidney Wilms tumor · adult malignant mesenchymoma · alveolar soft part sarcoma · cancer · central nervous system cancer · childhood kidney Wilms tumor · childhood malignant mesenchymoma · choroid plexus neoplasm · cutaneous melanoma · embryonal rhabdomyosarcoma · extragonadal germ cell tumor · germ cell tumor · invasive hydatidiform mole · leukemia · lymphoma · malignant testicular germ cell tumor · metastatic malignant neoplasm · mixed cell type kidney Wilms' tumor · myxofibrosarcoma · undifferentiated pleomorphic sarcoma · urinary bladder cancer · urothelial carcinoma · uterine corpus choriocarcinoma · childhood kidney neoplasm · Ewing sarcoma
Investigated by
National Cancer Institute (NCI) · Children's Oncology Group · Children's Cancer and Leukaemia Group · Memorial Sloan Kettering Cancer Center · Societe Francaise Oncologie Pediatrique · University of Leicester
+57 more · Dalian Maternity and Child Care Hospital · Gansu Provincial Maternal and Child Health Care Hospital · German Society for Pediatric Oncology and Hematology GPOH gGmbH · Gynecologic Oncology Group · Henan Cancer Hospital · Japan Rhabdomyosarcoma Study Group · Obstetrics & Gynecology Hospital of Fudan University · Peking Union Medical College Hospital · Shanghai Junshi Bioscience Co., Ltd. · Shengjing Hospital · Sichuan Cancer Hospital and Research Institute · St. Jude Children's Research Hospital · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · The First Affiliated Hospital of Xiamen University · Barts & The London NHS Trust · Children's Hospitals and Clinics of Minnesota · Dana-Farber Cancer Institute · Ding Ma · Dutch Childhood Oncology Group · EBMT Solid Tumors Working Party · Eastern Cooperative Oncology Group · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European Organisation for Research and Treatment of Cancer - EORTC · European Paediatric Soft Tissue Sarcoma Study Group · Fudan University · GOG Foundation · Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria · H. Lee Moffitt Cancer Center and Research Institute · Haukeland University Hospital · Helse Fonna · Helse Forde · Helse Møre og Romsdal HF · Helse Nord-Trøndelag HF · Helse Stavanger HF · Hospital of Southern Norway Trust · Huazhong University of Science and Technology · Innlandet Hospital Trust · International Society of Pediatric Oncology · Italian Association for Pediatric Hematology Oncology · Lovisenberg Diakonale Hospital · National Pediatric Cancer Foundation · Nordland Hospital · Oslo University Hospital · Ostfold Hospital Trust · Queen Mary University of London · Shandong University · St. Olavs Hospital · Swiss Cancer Institute · Sykehuset Telemark · The Hospital of Vestfold · Tufts Medical Center · University Hospital of North Norway · University Hospital, Akershus · University of Birmingham · Vestre Viken Hospital Trust · Zhejiang University · xiang yang

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) COSMEGEN 2018-08-15 fda.gov
Approved US (FDA) COSMEGEN 1964-12-10 fda.gov

Trials 50 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT04625907 Sep 2020 → Jun 2030 expected rhabdomyosarcoma University of Birmingham Recruiting No outcome recorded
Phase 221 trials
Phase 2 NCT07355855 Jan 2026 → Jan 2029 expected rhabdomyosarcoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT06020755 Dec 2024 → Aug 2025 overdue gestational trophoblastic neoplasm Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 2 NCT06023641 Mar 2024 → Oct 2034 expected rhabdomyosarcoma St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 2 NCT04817956 Apr 2021 → Mar 2040 expected metastatic malignant neoplasm Oslo University Hospital Recruiting No outcome recorded
Phase 2 NCT04388839 Dec 2020 → Aug 2026 overdue rhabdomyosarcoma H. Lee Moffitt Cancer Center and Research Institute Active not recruiting No outcome recorded
Phase 2 NCT04332874 Apr 2020 → Apr 2027 expected alveolar soft part sarcoma, myxofibrosarcoma, undifferentiated pleomorphic sarcoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT02788201 Mar 2017 → Oct 2019 urinary bladder cancer, urothelial carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 2 NCT01871766 Dec 2013 → Dec 2026 expected rhabdomyosarcoma St. Jude Children's Research Hospital Active not recruiting No outcome recorded
Phase 2 NCT01782339 May 2012 → May 2021 germ cell tumor Barts & The London NHS Trust Completed No outcome recorded
Phase 2 NCT06309732 Jul 2006 → Jun 2013 malignant testicular germ cell tumor Queen Mary University of London Completed No outcome recorded
Phase 324 trials
Phase 3 NCT07466316 Jun 2026 → Mar 2031 expected rhabdomyosarcoma Children's Oncology Group Not yet recruiting No outcome recorded
Phase 3 NCT06401330 Apr 2025 → Feb 2031 expected mixed cell type kidney Wilms' tumor Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT06647953 Mar 2025 → Mar 2029 expected pleuropulmonary blastoma Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT05304585 Aug 2022 → Jun 2030 expected embryonal rhabdomyosarcoma, spindle cell rhabdomyosarcoma Children's Oncology Group Recruiting No outcome recorded
Phase 3 NCT04994132 Sep 2021 → Jun 2026 overdue alveolar rhabdomyosarcoma, botryoid rhabdomyosarcoma, spindle cell rhabdomyosarcoma Children's Oncology Group Active not recruiting No outcome recorded
Phase 3 NCT02567435 Jun 2016 → Jun 2023 overdue alveolar rhabdomyosarcoma, botryoid rhabdomyosarcoma, spindle cell rhabdomyosarcoma National Cancer Institute (NCI) Active not recruiting No outcome recorded
Phase 3 NCT01823315 Dec 2012 → Dec 2015 gestational trophoblastic neoplasm Ding Ma Unknown No outcome recorded
Phase 3 NCT01535053 Jun 2012 → May 2018 choriocarcinoma, gestational trophoblastic neoplasm, hydatidiform mole GOG Foundation Completed No outcome recorded
Phase 3 NCT01014767 Nov 2009 → Oct 2013 brain cancer, choroid plexus neoplasm Tufts Medical Center Terminated No outcome recorded
Phase 3 NCT00945009 Aug 2009 → Dec 2016 Beckwith-Wiedemann syndrome, adult kidney Wilms tumor, childhood kidney Wilms tumor, rhabdoid tumor of the kidney Children's Oncology Group Completed No outcome recorded
Phase 41 trial
Phase 4 NCT00491946 Jun 2004 → ? cancer Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Unknown No outcome recorded
Phase not applicable3 trials
NCT06028672 Sep 2023 → Aug 2025 overdue gestational trophoblastic neoplasm Peking Union Medical College Hospital Recruiting No outcome recorded
NCT04562558 Sep 2020 → Nov 2024 overdue choriocarcinoma, invasive hydatidiform mole xiang yang Active not recruiting No outcome recorded
NCT01464606 Dec 2009 → Dec 2025 overdue pleuropulmonary blastoma Children's Hospitals and Clinics of Minnesota Active not recruiting No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT01531244 Background Dec 2014 → Feb 2016 melanoma Washington University School of Medicine Withdrawn No outcome recorded
Phase 26 trials
Phase 2 NCT06861244 Background Mar 2025 → Sep 2030 expected embryonal tumor with multilayered rosettes University of California, San Francisco Recruiting No outcome recorded
Phase 2 NCT06699472 Background Oct 2024 → Sep 2026 expected Ewing sarcoma, chemotherapy-induced toxicity Fudan University Recruiting No outcome recorded
Phase 2 NCT05139095 Background Jan 2022 → Dec 2026 expected gestational trophoblastic neoplasm Peking Union Medical College Hospital Recruiting No outcome recorded
Phase 2 NCT01323517 Background Feb 2011 → Aug 2017 melanoma Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 2 NCT01055314 Background Jan 2010 → Jun 2016 alveolar rhabdomyosarcoma, embryonal rhabdomyosarcoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 37 trials
Phase 3 NCT03669783 Comparator Feb 2023 → Oct 2028 expected childhood kidney neoplasm Assistance Publique Hopitaux De Marseille Recruiting No outcome recorded
Phase 3 NCT04756713 Comparator Feb 2021 → Dec 2024 gestational trophoblastic neoplasm, hydatidiform mole Brigham and Women's Hospital Unknown No outcome recorded
Phase 3 NCT02639650 Comparator Mar 2016 → Mar 2024 gestational trophoblastic neoplasm Weiguo Lv Unknown No outcome recorded
Phase 3 NCT02063022 Comparator Jan 2009 → Apr 2022 Ewing sarcoma Italian Sarcoma Group Completed No outcome recorded
Phase 3 NCT00002611 Comparator Jul 1995 → Jun 2002 kidney cancer Children's Oncology Group Completed No outcome recorded
Phase not applicable1 trial
NCT00541411 Background Jun 2003 → Jun 2013 Ewing sarcoma King Faisal Specialist Hospital & Research Center Unknown No outcome recorded

Evidence & citations 22 cited values

Every value below carries the sentence it was read from. 66 sources stand behind the page.

FieldValueCited text
Known as dactinomycin “One or more of the following may be assigned by the physician (physician's choice) per standard of care guidelines upon study enrollment following surgery: Cytarabine,...” NCT06861244
50

“Induction treatment with: 4 cycle of Vincristine (9mg/,2), Dactinomycin (6mg/m2), Doxorubicin (160mg/m2), Cyclophosphamide (2.4g/m2), Ifosfamide (18g/M2) and Etoposide...” NCT02063022

“Regimen: dactinomycin d 0.6mg/m2, IV, on day1, 2; methotrexate 100mg/m2, IV, on day1 (after Act-d); methotrexate 200mg/m2, IVgtt, on day1 (after methotrexate, 500ml NS, \>4h).” NCT01823315

Dactinomycin (A), intravenous infusion, 1.25mg/m2” NCT07355855

“Dacarbazine, Dactinomycin, Dasatinib” NCT02788201

NCT00354744

NCT01323517

NCT00354835

NCT00002516

NCT06647953

NCT00002766

NCT05304585

NCT00945009

NCT04562558

NCT00084838

NCT00020566

NCT00003955

NCT06023641

NCT00002995

NCT06309732

NCT06401330

NCT00003804

NCT00003688

NCT01535053

NCT00335556

NCT00245141

NCT00352534

NCT00075582

NCT01055314

NCT00003958

NCT00002898

NCT00025103

NCT00002611

NCT00245089

NCT00003702

NCT00025441

NCT01871766

NCT02567435

NCT00047138

NCT01531244

NCT00379340

NCT00072280

NCT01464606

NCT07466316

NCT04994132

NCT00002610

NCT01014767

NCT00004250

NCT04332874

NCT00379457

NCT00002489

Known as Act-D “In cases of chemoresistance, second-line chemotherapy will be performed with actinomycin-D (Act-D) 1.25 mg intravenous pulse every 14 days.” NCT04756713
Known as Actinomycin c1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Actinomycin i1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Actinomycin iv ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Actinomycin x1 ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Actinomycin-D “In cases of chemoresistance, second-line chemotherapy will be performed with actinomycin-D (Act-D) 1.25 mg intravenous pulse every 14 days.” NCT04756713
15

“patients with metastatic RMS received four cycles of ifosfamide, vincristine, and actinomycin D (IVA) plus doxorubicin” PMID 35709412 Jun 2022

“Day 1 Actinomycin D 1mg/m2, Paclitaxel 80mg/m2, Methotrexate Day 4 Oxaliplatin 100mg/m2 Pegfilgrastim 6mg” NCT01782339

“Pulse Actinomycin-D as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Neoplasia” NCT00003688

“etoposide, methotrexate, actinomycin D/cyclophosphamide, vincristine, alternate weekly” NCT05139095

“1 x Actinomycin D 45µg/kg iv bolus day 1 in week 1, 3, 5” NCT03669783

“replace it with actinomycin D 1.25mg/m2” NCT06699472

“treatment Actinomycin-DNCT03669783

“Actinomycin D” NCT04817956

NCT04625907

NCT06028672

NCT02639650

NCT06020755

NCT00541411

NCT00491946

NCT04388839

Known as Cosmegen ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Cosmegen lyovac ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as DACT “regimen EE-4A comprising dactinomycin (DACT) IV weekly on weeks 0, 3, 6, 9, 12, 15, and 18” NCT00002611
1

“Patients receive dactinomycin (DACT) IV on weeks 0, 3, 6, 9, 12, 15, and 18” NCT00002610

Known as Dactinomicina ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Dactinomycine ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Dactinomycinum ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Dilactone actinomycin d acid ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as GNF-Pf-1977 ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as GNF-PF-2290 ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Meractinomycin ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as NCI-C04682 ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as NSC-3053 ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Known as Oncostatin k ChEMBL registry synonym — accepted as the source's own label CHEMBL1554
Modality Protein / enzyme biologic CHEMBL1554
Route Intravenous “dactinomycin IV on days 1-3” NCT00002489