A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia

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

Summary:

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 subjects with acute myeloid leukemia (AML).

Trial Description

Primary Outcome:

• Dose Limiting Toxicity (DLT)
• Maximum Tolerated Dose (MTD)
• Adverse Events (AEs)

Secondary Outcome:

• Complete Remission Rate (CRR),
• Objective Response Rate (ORR)
• Progression Free Survival (PFS)
• Overall Survival (OS)
• Duration of Remission
• Time to Remission
• Pharmacokinetics - Cmax
• Pharmacokinetics - AUC24
• Pharmacokinetics - t1/2

Study CC-90009-AML-002 is an open-label, multi-arm, parallel multi-cohort, multicentre, 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.

View this trial on ClinicalTrials.gov