Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03760523|
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : August 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Minnelide||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/1b Dose Escalation Study of Minnelide in Relapsed or Refractory Acute Myeloid Leukemia|
|Actual Study Start Date :||April 18, 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2023|
Experimental: Minnelide Dose Escalation
A 3+3 design will be used. The first 3 patients will be treated at dose level 1. If none experience a Dose Limiting Toxicity (DLT), the next 3 patients will be treated at dose level 2. If a DLT is observed in 1 out of 3 patients at dose level 1, up to an 3 more patients will be enrolled and treated at that dose level. If 2 patients at dose level have DLTs, dosing will be lowered to dose level -1 (.5 mg daily, taken orally). If 2 or more of the up to 6 patients at any dose level have DLTs, the preceding dose will be declared the Maximum Tolerated Dose (MTD). If more than 1 DLT occurs at Dose Level -1, the investigators will consider stopping the study. Once the MTD has been established, an additional 10 patients will be enrolled at this level to better characterize safety and tolerability.
Patients will take Minnelide orally once daily on Days 1-21 of 28 day Cycle. Dose Escalation Schedule: Dose Level -1: .5 mg, Dose Level 1: .75 mg, Dose Level 2: 1 mg, Dose Level 3: 1.25 mg.
- Maximum Tolerated Dose (MTD) of Minnelide [ Time Frame: Up to 28 days for each dosing cohort ]MTD will be determined by testing increasing doses up to 1.25 mg daily. MTD reflects highest dose of drug that did not cause a Dose Limiting Toxicity (DLT).
- Number of Participants Who Experience Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days for each dosing cohort ]A DLT is any Grade 3 or 4 drug-related non-hematologic toxicity, with some exceptions per protocol.
- Complete Response (CR) [ Time Frame: Up to 12 months ]Participants who experience Complete Response (CR) and Complete Response with Incomplete Blood Count Recovery (CRi) rate as defined by 2003 International Working Group (IWG) for AML.
- Overall Response Rate (ORR) [ Time Frame: Up to 12 months ]Overall Response Rate is defined as CR + CRi + partial response (PR) as defined by 2003 IWG criteria for AML.
- Relapse Free Survival (RFS) [ Time Frame: Up to 18 months ]RFS is defined as time interval between achievement of CR to time of relapse.
- Overall Survival (OS) [ Time Frame: Up to 12 months ]OS defined as time interval from time of enrollment onto the clinical trial to death from any cause.
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): NCT03760523
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Maha Balouch 813-745-8650 Maha.Balouch@moffitt.org|
|Sub-Investigator: David Sallman, MD|
|Sub-Investigator: Jeffrey Lancet, MD|
|Sub-Investigator: Rami Komrokji, MD|
|Sub-Investigator: Mohammad Hussaini, MD|
|Sub-Investigator: Eric Padron, MD|
|Principal Investigator:||Kendra L Sweet, MD||H. Lee Moffitt Cancer Center and Research Institute|