Study on Abemaciclib Versus Placebo for Patients with Advanced Dedifferentiated Liposarcoma
Sponsor: Sarcoma Alliance for Research through Collaboration
ClinicalTrials ID:NCT04967521
This clinical trial is comparing the effects of the drug abemaciclib with a placebo in patients with advanced dedifferentiated liposarcoma, a type of cancer. Patients whose cancer worsens while on placebo may switch to abemaciclib if they meet certain conditions.
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Program Overview
This study is testing whether abemaciclib, a medication, is more effective than a placebo in treating patients with advanced dedifferentiated liposarcoma, a type of cancer that has returned or spread. Participants will be randomly assigned to receive either abemaciclib or a placebo. If the cancer progresses while on placebo, patients may switch to abemaciclib, provided they still meet the study's requirements. The study aims to determine if abemaciclib can help control the disease better than a placebo.
Description
This clinical trial involves patients with advanced dedifferentiated liposarcoma, a type of cancer that has come back or spread to other parts of the body. Participants will be randomly assigned to receive either the drug abemaciclib or a placebo, which is a substance with no active medication. The study is double-blind, meaning neither the patients nor the researchers know who is receiving the actual drug or the placebo.
Patients will be monitored for any changes in their cancer. If the cancer worsens while on placebo, they may be allowed to switch to abemaciclib if they still qualify for the study. This switch is only allowed if the cancer's progression is confirmed by scans, not just symptoms. The study will help determine if abemaciclib is effective in controlling the disease compared to a placebo.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of dedifferentiated liposarcoma that has returned or spread.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have at least one measurable tumor on a CT or MRI scan.
- Have good organ function as determined by specific medical tests.
- Be able to swallow pills.
- Have recovered from any recent radiation or chemotherapy treatments.
- Agree to use effective birth control during the study and for three weeks after the last dose of the study drug.
- Women must have a negative pregnancy test before starting the study.
- Have evidence of cancer progression as defined by specific criteria.
- Patients with brain metastases are eligible if they have been treated and are stable.
Exclusion Criteria
- Have only well-differentiated liposarcoma, which grows slowly.
- Have large tumors needing immediate chemotherapy.
- Have previously taken abemaciclib or similar drugs.
- Have another active cancer within the last year.
- Have severe or uncontrolled medical conditions that could pose safety risks.
- Have had major surgery within the last three weeks.
- Have resectable cancer that can be removed with surgery.
- Have digestive issues affecting pill absorption.
- Are pregnant or breastfeeding.
- Have an allergy to abemaciclib.
- Have untreated brain cancer.
- Cannot follow study procedures.
- Are taking medications that interact with abemaciclib.
- Have serious preexisting medical conditions that would prevent participation.
- Have active infections requiring treatment.
- Have a history of certain heart conditions.
- Have participated in another clinical trial recently.
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