Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers
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|ClinicalTrials.gov Identifier: NCT04092179|
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Relapsed Cancer Refractory Cancer IDH2 Gene Mutation||Drug: Enasidenib Drug: Venetoclax||Phase 1 Phase 2|
This study will have two parts: Phase 1b and Phase 2. The part that patients may participate in will depend on when they join the study.
In the phase 1b portion of the study, small groups participants will receive increasing doses of venetoclax in combination with a flat dose of enadisenib until the highest dose or best dose of venetoclax that is safe and tolerable in combination with enadisenib is found.
In the phase 2 portion of the study, an additional group of participants will receive the highest or best dose of venetoclax found in the Phase 1b portion of the study with a flat dose of enadisenib to see how useful the combination is in treating relapsed or refractory acute myeloid leukemia (AML).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/II Study of IDH2 Inhibitor Enasidenib in Combination With BCL2 Inhibitor Venetoclax in Patients With IDH2-Mutated Myeloid Malignancies (ENAVEN-AML)|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Venetoclax and Enadisenib
Enasidenib and venetoclax will be taken by mouth (orally), once a day, every day, continuously.
Every 28-day period will be called a cycle. Participants will start venetoclax alone on Cycle 1 Day 1 and continue the study drug alone until Day 15. On Day 15, participants will take enasidenib and venetoclax together and will continue to take the combination of study drugs until intolerable side effects or disease worsening.
Enasidenib is a drug that blocks a protein called isocitrate dehydrogenase (IDH) 2 from working. The family of IDH proteins have been indicated in the development of leukemia. By blocking IDH2, enasidenib may help stop cancer cells from growing. It is believed that the drug may be more useful in patients with a change (mutation) in their IDH 2 protein. The IDH2 gene (substances in the body that contain instructions for the proper development and function of cells) makes IDH2 proteins. As such, only patients with IDH 2 mutated gene are eligible for this study. Enasidenib is currently approved for the treatment of IDH2 mutated AML.
Other Name: IDHIFA
Venetoclax is a drug that blocks a protein called B-cell lymphoma (BCL2) protein from working. BCL2 is a protein that helps control whether a cell lives or dies and is thought to help cancer cells to live. Blocking BCL2 is believed to help kill cancer cells. Venetoclax is currently approved for the treatment of type of blood cancer called chronic lymphocytic leukemia (CLL) who have received prior treatment.
Other Name: VENCLEXTA
- Overall response rate (ORR) [ Time Frame: 3 years ]
- Dose Limiting Toxicity [ Time Frame: 28 days ]
- Maximum tolerated dose or Recommended Phase 2 Dose [ Time Frame: 3 years ]Dose indicated by the mTPI decision
- Duration of Response [ Time Frame: 3 years ]The time from the date of first response until progression, relapse, death, or last follow‐up.
- Overall Survival [ Time Frame: 3 years ]The first day of treatment until death or last contact.
- Event Free Survival [ Time Frame: 3 years ]The number of days from the first day of treatment to the date of earliest evidence of relapse or progression, subsequent treatment other than stem cell transplant while in response, or death, or date of last disease assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092179
|Contact: Steven Chan, M.D.||416‐946‐email@example.com|
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 1Z5|
|Contact: Steven Chan, M.D. 416‐946‐2253 firstname.lastname@example.org|
|Principal Investigator: Steven Chan, M.D.|
|Principal Investigator:||Steven Chan, M.D.||Princess Margaret Cancer Centre|