Actively Recruiting
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
74
Participants Needed
1
Research Sites
45 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase 1: Adults with advanced or metastatic soft tissue sarcoma who have had at least one prior standard systemic therapy
- Phase 2: Adults with advanced or metastatic leiomyosarcoma or dedifferentiated liposarcoma for which gemcitabine and docetaxel is standard treatment; no prior gemcitabine allowed
- Measurable or assessable tumor present
- Tumor sample shows intact retinoblastoma (Rb) gene expression
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 60% or higher)
- Absolute neutrophil count at least 1.2K/µL
- Hemoglobin at least 9.0 g/dL
- Platelet count at least 100K/mm³
- Glomerular filtration rate at least 60 mL/min (no lower than 30 mL/min with supporting data)
- Total bilirubin within 1.5 times institutional normal limit (up to 2.0 for Gilbert's syndrome)
- AST and ALT no higher than 1.5 times institutional normal limit
- HIV patients on effective therapy with undetectable viral load within 6 months
- Patients with chronic hepatitis B must have undetectable viral load on therapy
- Patients with hepatitis C must be cured or have undetectable viral load if on treatment
- Treated brain metastases with no progression on follow-up imaging
- Prior or concurrent malignancies that do not affect safety or efficacy assessment
- Cardiac function class II congestive heart failure or better
- Life expectancy greater than 6 months
- Negative pregnancy test for women of childbearing potential and use of contraception during and up to 6 months after treatment
- Men must use contraception during and up to 4 months after treatment
- Ability to understand and sign informed consent
- Able to swallow oral medications
You will not qualify if you...
- Not recovered from side effects of prior anti-cancer therapy above grade 1 (except hair loss)
- Receiving other investigational drugs within 30 days or 5 half-lives
- Allergic reactions to abemaciclib or gemcitabine or similar compounds
- Uncontrolled illnesses or other conditions making participation hazardous
- Pregnant or breastfeeding women
- Use of strong CYP3A4 inhibitors that cannot be stopped before study
- Progression on prior CDK4 inhibitor therapy
- Phase 2 only: prior gemcitabine-based chemotherapy
- Significant cardiac disease including certain arrhythmias or sudden cardiac arrest
- Interstitial lung disease
- Gastrointestinal conditions affecting oral drug absorption
- Radiation therapy within 7 days or less before gemcitabine
- Major surgery within 14 days before randomization
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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