SARC041: Study of Abemaciclib Versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma (NCT04967521) | Clinical Trial Compass
Active — Not RecruitingPhase 3
SARC041: Study of Abemaciclib Versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma
United States108 participantsStarted 2021-11-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years
* Histologically confirmed diagnosis of dedifferentiated liposarcoma which is locally recurrent and/or metastatic. This study will accept the diagnosis made at the investigator's center.
* ECOG Performance Status of 0 or 1.
* At least one site of measurable disease on CT/MRI scan as defined by RECIST 1.1 criteria. Baseline imaging must be performed within 28 days of Day 1 of study.
* Adequate organ function
* The patient can swallow oral medications.
* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy).
* Written, voluntary informed consent
* Fertile men and women of childbearing potential must agree to use a highly effective method of birth control during the treatment period and for 3 weeks after last study drug administration in both sexes. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing pot…
What they're measuring
1
To determine the progression-free survival of patients treated with abemaciclib versus placebo
Timeframe: 5 years
Trial details
NCT IDNCT04967521
SponsorSarcoma Alliance for Research through Collaboration