A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Myelosuppression
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 120
Summary
- Conditions
- Non -Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
During the Phase 1b portion of the study, topotecan will be administered per standard practice on Days 1-5 of 21-day cycles. Patients will be randomized to receive 1 of 2 initial ALRN-6924 dose levels, to be administered prior to each planned topotecan dose. The incidence, severity and duration of h...
During the Phase 1b portion of the study, topotecan will be administered per standard practice on Days 1-5 of 21-day cycles. Patients will be randomized to receive 1 of 2 initial ALRN-6924 dose levels, to be administered prior to each planned topotecan dose. The incidence, severity and duration of hematologic toxicities, including neutropenia, thrombocytopenia, and febrile neutropenia, will be determined. The safety and tolerability of each ALRN-6924 dose level will be assessed during Phase 1b. If pre-determined criteria for safety and myelopreservation activity are met and the RP2D is identified, the Phase 2 portion of the study will be triggered. In Phase 2, patients with ED SCLC requiring 2nd line treatment with topotecan will be randomized 1:1 to either receive topotecan alone or topotecan with supportive ALRN-6924 treatment.
Tracking Information
- NCT #
- NCT04022876
- Collaborators
- Not Provided
- Investigators
- Not Provided
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