NCT04336982

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 participants with acute myeloid leukemia (AML).

Detailed description

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.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	CC-90009	Injection
DRUG	Venetoclax	Tablet
DRUG	Azacitidine	Injection
DRUG	Gilteritinib	Tablet

Timeline

• Start date: 2020-08-05
• Primary completion: 2023-10-25
• Completion: 2024-04-05
• First posted: 2020-04-07
• Last updated: 2024-05-31

Locations

14 sites across 5 countries: United States, Belgium, Canada, France, United Kingdom

Regulatory

• FDA-regulated drug study