RecruitingPhase 1Phase 2NCT06498648

Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma

Phase I/II Study to Evaluate the Feasibility and Efficacy of Sequential Abemaciclib and Gemcitabine Treatment in Patients With Retinoblastoma (Rb)+ Sarcomas


Sponsor

National Cancer Institute (NCI)

Enrollment

74 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the side effects and best dose of abemaciclib when added to gemcitabine and compares the effectiveness of that treatment to the usual treatment of gemcitabine with docetaxel for the treatment of patients with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) (phase 1) or patients with leiomyosarcoma or dedifferentiated liposarcoma (phase 2). Abemaciclib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic soft tissue sarcoma or leiomyosarcoma or dedifferentiated liposarcoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding abemaciclib (a targeted cancer drug that blocks cell growth) to gemcitabine chemotherapy can improve outcomes in patients with advanced soft tissue sarcomas, particularly leiomyosarcoma and liposarcoma. **You may be eligible if...** - You have advanced or metastatic soft tissue sarcoma confirmed by pathology - For Phase 1: you have received at least one prior cancer treatment (prior gemcitabine is allowed) - For Phase 2: your specific sarcoma type is leiomyosarcoma or dedifferentiated liposarcoma, and gemcitabine plus docetaxel is a standard treatment option (prior gemcitabine not allowed) - Your tumor shows intact Rb gene expression - You have at least one measurable tumor and adequate organ function **You may NOT be eligible if...** - Your tumor has lost Rb gene expression - You have received prior treatment that disqualifies you based on phase-specific rules - You have serious heart conditions, active infections, or brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAbemaciclib

Given PO

PROCEDUREBiopsy Procedure

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

DRUGDocetaxel

Given IV

DRUGGemcitabine

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT06498648


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