Dactinomycin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
Also used as a comparator or background therapy in 15 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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| Phase 1/2 | NCT01531244 Background | Dec 2014 → Feb 2016 | melanoma | Washington University School of Medicine | Withdrawn | No outcome recorded |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 2 | NCT00643565 Background | Jul 2008 → May 2015 | sarcoma | Hoffmann-La Roche | 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 3 | NCT00002898 Background | Jan 1995 → Dec 2009 | undifferentiated high grade pleomorphic sarcoma of bone | International Society of Pediatric Oncology | Completed | No outcome recorded |
| Phase 3 | NCT00002516 Background | Jul 1992 → ? | sarcoma | University Hospital Muenster | Unknown | 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.
| Field | Value | Cited 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 ↗ |
| 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-D” NCT03669783 ↗ “Actinomycin D” NCT04817956 ↗ |
| 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 ↗ |