Study on Adding Abemaciclib to Usual Chemotherapy for Soft Tissue Sarcoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06498648

Provider View

This clinical trial is exploring whether adding the drug abemaciclib to the usual chemotherapy treatment with gemcitabine can be safe and effective for patients with advanced or metastatic soft tissue sarcoma. The study compares this new combination to the standard treatment of gemcitabine and docetaxel.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with advanced or metastatic soft tissue sarcoma. It involves adding a drug called abemaciclib to the usual chemotherapy drug, gemcitabine, and comparing it to the standard treatment of gemcitabine and docetaxel. Abemaciclib works by blocking a protein that helps cancer cells grow, while gemcitabine and docetaxel are chemotherapy drugs that kill cancer cells. The study aims to find the best dose of abemaciclib and see if this combination is more effective than the standard treatment.

Description

The study is divided into two phases. In Phase I, the goal is to find the best schedule and dose of abemaciclib when combined with gemcitabine for treating certain types of soft tissue sarcoma. In Phase II, the study will compare how well this new combination works against the standard treatment of gemcitabine and docetaxel in patients with specific types of sarcoma.

In Phase I, patients are divided into two groups to test different schedules of taking abemaciclib and gemcitabine. Patients in Cohort I take abemaciclib by mouth twice a day for five days, followed by gemcitabine given through an IV. In Cohort II, patients take abemaciclib for seven days, followed by gemcitabine. The treatment cycles repeat every 21 or 28 days for up to two years, as long as the cancer does not progress and side effects are manageable.

In Phase II, patients are randomly assigned to one of two groups. In Arm A, patients receive the abemaciclib and gemcitabine combination based on the best schedule found in Phase I. In Arm B, patients receive the standard treatment of gemcitabine and docetaxel. If the cancer progresses, patients can switch to the other treatment arm. The study will monitor patients' response to treatment, side effects, and overall survival.

Throughout the study, patients will have regular blood tests and scans to check their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every three months for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Have advanced or metastatic soft tissue sarcoma and have tried at least one standard treatment before (Phase I).
  • Have advanced or metastatic leiomyosarcoma or dedifferentiated liposarcoma and have not received gemcitabine before (Phase II).
  • Have a tumor that can be measured or assessed.
  • Have a specific gene expression in the tumor, confirmed by a test.
  • Be 18 years or older.
  • Be in good overall health with a performance status that allows for daily activities.
  • Have adequate blood cell counts and organ function based on specific tests.
  • Have a life expectancy of more than six months.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study and for six months after.
  • Men must agree to use contraception during the study and for four months after.
  • Be able to swallow oral medications.
  • Understand and agree to sign a consent form.

Exclusion Criteria

  • Have not recovered from side effects of previous cancer treatments, except for hair loss.
  • Are taking other investigational drugs or have taken them recently.
  • Have allergies to similar drugs as abemaciclib or gemcitabine.
  • Have uncontrolled illnesses or conditions that make participation unsafe.
  • Are pregnant or breastfeeding.
  • Are taking certain medications that cannot be stopped before the study.
  • Have progressed on previous CDK4 inhibitor therapy.
  • Have significant heart disease or lung disease.
  • Have gastrointestinal issues affecting medication absorption.
  • Have had recent radiation therapy or major surgery.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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