NCT04967521

SARC041: Study of Abemaciclib Versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma

SARC041: Phase 3 Randomized Double-Blind Study of Abemaciclib Versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Sarcoma Alliance for Research through Collaboration · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 randomized double-blind study of abemaciclib versus placebo. Patients with progression of disease will cross over to open label abemaciclib.

Detailed description

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study of patients with advanced, recurrent and/or metastatic DDLS. Patients will be randomized 1:1 between abemaciclib and placebo and followed for disease progression. For those patients with progression of disease (by RECIST) on placebo, crossover to active drug will be offered to patients if they remain eligible for the clinical trial in all other respects. Unblinding and crossover is only allowed for radiographic progression (not clinical progression). Real-time radiology review by the treating physician will allow for rapid crossover for patients with progression on placebo. If patients are deemed to have disease that is too rapidly progressive to be considered for a randomized, double-blind, placebo-controlled clinical trial, they should be excluded from consideration.

Conditions

• Advanced Dedifferentiated Liposarcoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Abemaciclib will be administered 200mg orally twice a day. Each cycle is 28 days.
DRUG	Placebo	Placebo will be administered orally twice a day. Each cycle is 28 days.

Timeline

• Start date: 2021-11-11
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2021-07-19
• Last updated: 2024-12-06

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study