OncoMatch/Clinical Trials/NCT06498648
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
Is NCT06498648 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Abemaciclib and Docetaxel for advanced dedifferentiated liposarcoma.
Treatment: Abemaciclib · Docetaxel · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Required: RB1 intact expression (intact)
Patients must have intact Rb gene expression in the baseline tumor biopsy or archived tumor sample, as assessed by immunohistochemistry
Disease stage
Required: Stage III, IV (AJCC v8)
Metastatic disease required
advanced/metastatic...Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Phase 1: ...have received at least one prior standard systemic therapy (prior gemcitabine is allowed)
Cannot have received: CDK4 inhibitor
Progression on prior CDK4 inhibitor therapy
Cannot have received: gemcitabine-based chemotherapy (gemcitabine)
Exception: Phase 2 only
Phase 2 only: Prior gemcitabine-based chemotherapy
Lab requirements
Blood counts
Absolute neutrophil count > 1.2K/µL; Hemoglobin > 9.0 g/dL; Platelets > 100K/mm^3
Kidney function
Glomerular filtration rate (GFR) ≥ 60 mL/min unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min
Liver function
Total bilirubin ≤ 1.5 × institutional ULN, patient with Gilbert's syndrome ≤ 2.0 times ULN, or direct bilirubin within normal limits; AST ≤ 1.5 × institutional ULN; ALT ≤ 1.5 × institutional ULN
Cardiac function
NYHA class II or better; no significant cardiac disease (no syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest)
Absolute neutrophil count > 1.2K/µL; Hemoglobin > 9.0 g/dL; Platelets > 100K/mm^3; GFR ≥ 60 mL/min unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min; Total bilirubin ≤ 1.5 × institutional ULN, patient with Gilbert's syndrome ≤ 2.0 times ULN, or direct bilirubin within normal limits; AST ≤ 1.5 × institutional ULN; ALT ≤ 1.5 × institutional ULN; NYHA class II or better; no significant cardiac disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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