MedTrace Logo

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

NCT04967521 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-12-06

No results posted yet for this study

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.

Conditions

  • Advanced Dedifferentiated Liposarcoma

Interventions

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.

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Sarcoma Alliance for Research through Collaboration

    lead OTHER

Principal Investigators

  • Mark Dickson, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04967521 on ClinicalTrials.gov