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Compound · clinical trials

Dactinomycin clinical trials

Also listed in trial records as Actinomycin C1, Actinomycin I1
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 7 trials in our Canada, Australia, Israel, China and Mexico registers that name Dactinomycin as an intervention. Synced 27 Sep 2026
7Current trials
4Recruiting now
3Lead sponsors
5Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Dactinomycin is named as an intervention in 7 current clinical trials in our Canada, Australia, Israel, China and Mexico registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Children's Oncology Group (5). The most-studied condition is Embryonal Rhabdomyosarcoma.

Where Dactinomycin is approved

All regulators →

Dactinomycin was first approved in the US on 10 Dec 1964. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
10 Dec 1964
Cosmegen
NDA050682 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
29 Aug 2018
Cosmegen
Notice of Compliance 21259
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Trials by status

  • Recruiting457%
  • Active, closed343%

Trials by phase

  • Phase 3686%
  • Not applicable114%
01

Clinical trials of Dactinomycin

7 trials
StudyPhaseStatusLead sponsorRegisters
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
NCT05304585 · ClinicalTrials.gov ↗ · Embryonal Rhabdomyosarcoma, Fusion-Negative Alveolar Rhabdomyosarcoma, Spindle Cell/Sclerosing Rhabdomyosarcoma
Phase 3 Recruiting Children's Oncology Group Canada, Mexico, Australia, Israel
A Study Using Risk Factors to Determine Treatment for Children With Favorable Histology Wilms Tumors (FHWT)
NCT06401330 · ClinicalTrials.gov ↗ · Stage I Mixed Cell Type Kidney Wilms Tumor, Stage II Mixed Cell Type Kidney Wilms Tumor, Stage III Mixed Cell Type Kidney Wilms Tumor
Phase 3 Recruiting Children's Oncology Group Canada, Australia, Israel
Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma
NCT06647953 · ClinicalTrials.gov ↗ · Pleuropulmonary Blastoma
Phase 3 Recruiting Children's Oncology Group Canada
A Study Comparing Higher Dose Chemotherapy Over a Shorter Amount of Time to Lower Dose Chemotherapy Plus Maintenance Over a Longer Amount of Time in Patients With Newly Diagnosed Intermediate-Risk Rhabdomyosarcoma (IR RMS)
NCT07466316 · ClinicalTrials.gov ↗ · Rhabdomyosarcoma
Phase 3 Recruiting Children's Oncology Group Canada
Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma
NCT02567435 · ClinicalTrials.gov ↗ · Alveolar Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma
Phase 3 Active, closed National Cancer Institute (NCI) Canada, Australia, Israel
A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma
NCT04994132 · ClinicalTrials.gov ↗ · Alveolar Rhabdomyosarcoma, Botryoid-Type Embryonal Rhabdomyosarcoma, Embryonal Rhabdomyosarcoma
Phase 3 Active, closed Children's Oncology Group Canada, Australia, Israel
Biweekly Actinomycin-D Treatment or Multi-day Methotrexate Protocol in Low-risk Gestational Trophoblastic Neoplasia
NCT04562558 · ClinicalTrials.gov ↗ · Gestational Trophoblastic Tumor, Gestational Trophoblastic Neoplasia, Stage I Gestational Trophoblastic Tumor
Not applicable Active, closed xiang yang China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Dactinomycin

16 conditions
Embryonal Rhabdomyosarcoma3Rhabdomyosarcoma2Alveolar Rhabdomyosarcoma2Botryoid-Type Embryonal Rhabdomyosarcoma2Gestational Trophoblastic Tumor1Gestational Trophoblastic Neoplasia1Stage I Gestational Trophoblastic Tumor1Stage II Gestational Trophoblastic Tumor1Pleuropulmonary Blastoma1Fusion-Negative Alveolar Rhabdomyosarcoma1Spindle Cell/Sclerosing Rhabdomyosarcoma1Stage I Mixed Cell Type Kidney Wilms Tumor1
All 16 conditions
Condition (as registered)Trials
Embryonal Rhabdomyosarcoma3
Rhabdomyosarcoma2
Alveolar Rhabdomyosarcoma2
Botryoid-Type Embryonal Rhabdomyosarcoma2
Gestational Trophoblastic Tumor1
Gestational Trophoblastic Neoplasia1
Stage I Gestational Trophoblastic Tumor1
Stage II Gestational Trophoblastic Tumor1
Pleuropulmonary Blastoma1
Fusion-Negative Alveolar Rhabdomyosarcoma1
Spindle Cell/Sclerosing Rhabdomyosarcoma1
Stage I Mixed Cell Type Kidney Wilms Tumor1
Stage II Mixed Cell Type Kidney Wilms Tumor1
Stage III Mixed Cell Type Kidney Wilms Tumor1
Stage IV Mixed Cell Type Kidney Wilms Tumor1
Metastatic Embryonal Rhabdomyosarcoma1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Children's Oncology Group5
xiang yang1
National Cancer Institute (NCI)1
04

By country register

RegisterTrialsRecruiting
Clinical trials in Canada64
Clinical trials in Australia42
Clinical trials in Israel42
Clinical trials in China10
Clinical trials in Mexico11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Dactinomycin trials

How many clinical trials are testing Dactinomycin?

7 current trials in our Canada, Australia, Israel, China and Mexico registers name Dactinomycin (also registered as Actinomycin C1) as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Dactinomycin trials recruiting patients?

Yes. 4 of the 7 trials are recruiting: 4 with sites in Canada, 2 with sites in Australia, 2 with sites in Israel and 1 with sites in Mexico. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Dactinomycin clinical trials?

Children's Oncology Group (5), xiang yang (1) and National Cancer Institute (NCI) (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Dactinomycin works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Dactinomycin works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Dactinomycin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.