A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04336982|
Recruitment Status : Recruiting
First Posted : April 7, 2020
Last Update Posted : October 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myeloid, Acute||Drug: CC-90009 Drug: Venetoclax Drug: Azacitidine Drug: Gilteritinib||Phase 1 Phase 2|
Study CC-90009-AML-002 is an open-label, multi-arm, parallel multi-cohort, multicenter, Phase 1b study to determine the safety, tolerability, PK, and efficacy of CC 90009 in combination with anti-leukemia agents used for the treatment of AML. CC 90009 will be given as a combination therapy to subjects with newly diagnosed (ND) or relapsed or refractory (R/R) AML.
The dose and schedule finding part (Part A) of the study will evaluate the safety, PK and PD data, and preliminary efficacy information and determine the Part B dose and schedule for each arm.
The expansion part (Part B) of the study will further evaluate the safety and efficacy of the CC-90009 containing combination at or below the maximum tolerated dose (MTD) in the selected cohorts in order to determine the recommended Phase 2 dose (RP2D) for subjects with AML.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Phase 1/2 Open-Label Multi-Arm Trial to Evaluate the Safety and Efficacy of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia|
|Actual Study Start Date :||August 5, 2020|
|Estimated Primary Completion Date :||April 28, 2023|
|Estimated Study Completion Date :||April 28, 2023|
Experimental: CC-90009 in combination with venetoclax and azacitidine
CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Venetoclax will be administered orally QD.
Azacitidine will be administered intravenously or subcutaneously on planned dosing days for each cycle.
Experimental: CC-90009 in combination with gilteritinib
CC-90009 will be administered intravenously per dosing schedule in a 28-day cycle. Gilteritinib will be administered orally QD.
- Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]Number of participants with a DLT
- Maximum Tolerated Dose (MTD) [ Time Frame: Up to 28 days. ]The highest dose with DLT rate in Cycle 1 being lower than or close to the target level 0.3 and the toxicity probability within (0.25, 0.35) interval.
- Adverse Events (AEs) [ Time Frame: Up to 28 days after last dose of study drug. ]An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology.
- Complete Remission Rate (CRR), [ Time Frame: Up to 3 years ]is defined as the rate for any type of CR or CRh
- Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]is defined as the rate for all types of CRs and PR for AML.
- Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]is defined as the time from the first dose of study drug(s) to the first occurrence of relapse or progression or death from any cause
- Overall Survival (OS) [ Time Frame: Up to 3 years ]is measured as the time from the first dose of study drug(s) to death due to any cause and will be analyzed in a manner similar to that described for PFS.
- Duration of Remission [ Time Frame: Up to 3 years ]is measured from the time when criteria for CR/CRh/PR are first met (whichever is first recorded) until the first date at which relapse, or progressive disease is objectively documented.
- Time to Remission [ Time Frame: Up to 3 years ]is measured from the time when criteria for CR/CRh/PR are first met (whichever is first recorded)
- Pharmacokinetics - Cmax [ Time Frame: Until last CC-90009 dose in Cycle 3 (each cycle is 28 days. CC-90009 dosing days are Days 1-5 in Cycle 3) ]observed maximum concentration in plasma
- Pharmacokinetics - AUC24 [ Time Frame: Until last CC-90009 dose in Cycle 3 (each cycle is 28 days. CC-90009 dosing days are Days 1-5 in Cycle 3) ]area under the plasma concentration time-curve from time 0 to 24 hours postdose
- Pharmacokinetics - t1/2 [ Time Frame: Until last CC-90009 dose in Cycle 3 (each cycle is 28 days. CC-90009 dosing days are Days 1-5 in Cycle 3) ]terminal half life
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): NCT04336982
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Not yet recruiting|
|San Francisco, California, United States, 94143-0324|
|United States, Connecticut|
|Yale New Haven Hospital||Not yet recruiting|
|New Haven, Connecticut, United States, 06510|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, New Jersey|
|Hackensack University Medical Center||Not yet recruiting|
|Hackensack, New Jersey, United States, 07601|
|United States, Texas|
|The University of Texas - MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Not yet recruiting|
|Seattle, Washington, United States, 98109-1024|
|University of Alberta||Not yet recruiting|
|Edmonton, Alberta, Canada, T6G 2R7|
|Princess Margaret Cancer Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Maisonneuve-Rosemont||Not yet recruiting|
|Montreal, Quebec, Canada, H1T 2M4|
|Marseille, France, 13273|
|Hopital Haut Leveque||Recruiting|
|Pessac Cedex, France, 33604|
|Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole||Recruiting|
|Toulouse Cedex 9, France, 31059|
|Gustave Roussy||Not yet recruiting|
|Villejuif CEDEX, France, 94805|
|John Radcliffe Hospital||Not yet recruiting|
|Oxford, United Kingdom, OX3 9DU|
|Study Director:||Michael Pourdehnad, M.D.||Celgene|