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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
108
Abemaciclib will be administered 200mg orally twice a day. Each cycle is 28 days.
Placebo will be administered orally twice a day. Each cycle is 28 days.
University of Colorado Cancer Center, Anschutz Medical Campus
Aurora, Colorado, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
To determine the progression-free survival of patients treated with abemaciclib versus placebo
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Time frame: 5 years
To determine the objective response rate by RECIST 1.1
A patient will be deemed to have an objective response if they have a confirmed complete response or partial response as determined by RECIST v1.1
Time frame: 5 years
To determine PFS after crossover for patients initially randomized to placebo
PFS after crossover will only be determined for patients who were randomized to placebo. It will be measured from the start of abemaciclib treatment until the occurrence of disease progression or death due to any cause prior to documented disease progression.
Time frame: 5 years
To determine overall survival
The length of time from the start of treatment that patients diagnosed with sarcoma are still alive.
Time frame: 5 years
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Washington
Seattle, Washington, United States