Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Phase 2, Randomized, Open-Label Study of Azacitidine (Vidaza) vs MGCD0103 vs Azacitidine in Combination With MGCD0103 for the Treatment of Elderly Subjects With Newly Diagnosed AML or Intermediate-2 or High-Risk MDS
Sponsor: Mirati Therapeutics Inc.
Terminated
Celgene terminated its collaboration agreement with MethylGene for the development of MGCD0103. All Celgene-sponsored trials with MGCD0103 with be closed.
Listed as NCT00666497, this PHASE2 trial focuses on Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) and remains terminated or withdrawn. Sponsored by Mirati Therapeutics Inc., it has been updated 12 times since 2008, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)This randomized, 3-arm Phase 2 study will compare the safety and efficacy of single-agent azacitidine (currently 1 of 3 approved treatments for myelodysplastic syndrome \[MDS\]) to that of single-agent MGCD0103 and to that of combination therapy with MGCD0103 and azacitidine in elderly patients with acute myelogenous leukemia (AML) or intermediate-2 (Int-2) or high-risk MDS, for whom no standard of care exists. The goal of the study is to determine which of the 3 treatment arms are worthy of further investigation in a subsequent Phase 3 study of elderly subjects with AML or Int-2 or high-risk MDS.
This randomized, 3-arm Phase 2 study will compare the safety and efficacy of single-agent azacitidine (currently 1 of 3 approved treatments for myelodysplastic syndrome \[MDS\]) to that of single-agent MGCD0103 and to that of combination therapy with MGCD0103 and azacitidine in elderly patients with acute myelogenous leukemia (AML) or intermediate-2 (Int-2) or high-risk MDS, for whom no standard of care exists. The goal of the study is to determine which of the 3 treatment arms are worthy of further investigation in a subsequent Phase 3 study of elderly subjects with AML or Int-2 or high-risk MDS.
Status Flow
Change History
12 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE2
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Sep 2024 — Present [monthly]
Terminated PHASE2
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
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Apr 2022 — Jul 2024 [monthly]
Terminated PHASE2
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Dec 2021 — Apr 2022 [monthly]
Terminated PHASE2
▶ Show 7 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Terminated PHASE2
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Nov 2020 — Jan 2021 [monthly]
Terminated PHASE2
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Jun 2018 — Nov 2020 [monthly]
Terminated PHASE2
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May 2018 — Jun 2018 [monthly]
Terminated PHASE2
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Aug 2017 — May 2018 [monthly]
Terminated PHASE2
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Feb 2017 — Aug 2017 [monthly]
Terminated PHASE2
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Jan 2017 — Feb 2017 [monthly]
Terminated PHASE2
First recorded
Jun 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Mirati Therapeutics Inc.
For direct contact, visit the study record on ClinicalTrials.gov .