CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Local Institution - 104
San Francisco, California, United States
Local Institution - 107
New Haven, Connecticut, United States
Local Institution - 103
Boston, Massachusetts, United States
Dose Limiting Toxicity (DLT)
Number of participants with a DLT
Time frame: Up to 28 days
Adverse Events (AEs)
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.
Time frame: Up to 28 days after last dose of study drug.
Complete Remission Rate (CRR),
is defined as the rate for any type of CR or CRh
Time frame: Up to 3 years
Objective Response Rate (ORR)
includes all responses of complete remissions (CRs), Morphologic leukemia-free state (MLFS), and Partial remission (PR)
Time frame: Up to 3 years
Progression Free Survival (PFS)
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
Time frame: Up to 3 years
Overall Survival (OS)
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.
Time frame: Up to 3 years
Duration of Remission
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.
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Tablet
Local Institution - 101
St Louis, Missouri, United States
Local Institution - 108
Hackensack, New Jersey, United States
Local Institution - 105
Houston, Texas, United States
Local Institution - 102
Seattle, Washington, United States
Local Institution - UNK3
Yvoir, Belgium
Local Institution - 202
Edmonton, Alberta, Canada
Local Institution - 201
Toronto, Ontario, Canada
...and 4 more locations
Time frame: Up to 3 years
Time to Remission
is measured from the time when criteria for CR/CRh/PR are first met (whichever is first recorded)
Time frame: Up to 3 years
Pharmacokinetics - Cmax
observed maximum concentration in plasma
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)
Pharmacokinetics - AUC24
area under the plasma concentration time-curve from time 0 to 24 hours postdose
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)
Pharmacokinetics - t1/2
terminal half life
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)