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NCT02141477
Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
Phase 1 trial testing Omacetaxine in Leukemia in 2 participants. Terminated before completion.
22 June 2017
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 6 May 2015 |
| Primary completion | 22 June 2017 |
| Estimated completion | 22 June 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Omacetaxine — full drug profile →
- Decitabine (decitabine) — full drug profile →
Conditions studied
- Leukemia — all drugs for Leukemia →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
70 and older, any sex, with Leukemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02141477
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Omacetaxine
Trials testing the same drug.
- NCT04926285 — Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety an · Phase 1 · completed
- NCT02159872 — Omacetaxine in Patients With Intermediate-1 and Higher Risk Myelodysplastic Syndrome (MDS) Post Hypomethylating Agent (H · Phase 2 · completed
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Currently open trials in the same condition.
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Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
- NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02141477 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 13 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02141477.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing