Testing Abemaciclib with Chemotherapy for Soft Tissue Sarcoma
This study is testing a new approach for people with advanced soft tissue sarcoma, including leiomyosarcoma and dedifferentiated liposarcoma. It combines the anti-cancer drug abemaciclib with standard chemotherapy (gemcitabine, or gemcitabine and docetaxel). Abemaciclib is a kinase inhibitor, which means it works by blocking a protein that helps cancer cells grow. The study aims to find the best dose of abemaciclib when added to gemcitabine and to see how well this combination works compared to the usual chemotherapy. Success will be measured by how long people live without their cancer getting worse (progression-free survival). The study is currently recruiting and plans to enroll 74 participants.
- Study design
- This is an interventional study with a planned enrollment of 74 participants. It is a Phase I/II trial, meaning it first looks at side effects and dosage, then compares effectiveness.
- What's involved
- You would undergo tumor biopsies, blood sample collections, and CT scans. The study involves receiving abemaciclib orally and docetaxel intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- Progression-free survival will be measured from randomization until disease progression or death, up to 2 years. Blood thymidine kinase activity will be measured at baseline up to 2 years.
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NCT06498648
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~74 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:AbemaciclibBiopsy ProcedureBiospecimen CollectionComputed TomographyDocetaxelGemcitabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time course of blood thymidine kinase activity (TKa) (Phase 1 Part A)
Measured over Baseline up to 2 years
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Elise F Nassif · PRINCIPAL_INVESTIGATOR · University of Texas MD Anderson Cancer Center LAO
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Phase 1: Patients must have advanced/metastatic histologically confirmed soft tissue sarcoma and have received at least one prior standard systemic therapy (prior gemcitabine is allowed)
Phase 2: Patients must have advanced/metastatic pathologically confirmed leiomyosarcoma or dedifferentiated liposarcoma for which gemcitabine and docetaxel is considered standard-of-care, patients may be systemic-treatment naïve. Prior gemcitabine is not allowed
Patients must have presence of measurable/assessable tumor
Patients must have intact Rb gene expression in the baseline tumor biopsy or archived tumor sample, as assessed by immunohistochemistry (at MD Anderson: clone G3- 245, BD Pharmagen, RRID:AB\_385259, Clinical Laboratory Improvement Act \[CLIA\] certified antibody)
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of abemaciclib in combination with gemcitabine in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Absolute neutrophil count ˃ 1.2K/µL
Hemoglobin ˃ 9.0 g/dL
Platelets ˃ 100K/mm\^3
Glomerular filtration rate (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 upper limit of normal (ULN), patient with Gilbert's syndrome ≤ 2.0 times ULN, or direct bilirubin within normal limits
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) ≤ 1.5 × institutional ULN
Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 1.5 × institutional ULN
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patients should be class congestive heart failure (CHF) II or better
Patients must have a life expectancy of greater than 6 months
Females of childbearing potential must have a negative serum pregnancy test within one week of trial enrollment and be willing to use an adequate method of contraception to avoid pregnancy throughout the trial and for up to 6 months after the last dose of drug therapy. The effects of abemaciclib on the developing human fetus are unknown. For this reason and because CDK 4/6 inhibiting agents as well as gemcitabine are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of abemaciclib administration. Abstinence is considered an effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study ranging from three weeks prior to initiation of treatment and up to 6 months after the last dose of treatment
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Patient is capable of swallowing oral medications
Exclusion
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
Patients who are receiving any other investigational agents. There must be no investigational drug use within 30 days or 5 half-lives of receiving the first dose of treatment on this treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib or gemcitabine
Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous
Pregnant women are excluded from this study because abemaciclib is a CDK4/6 inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with abemaciclib or gemcitabine, breastfeeding should be discontinued if the mother is treated with abemaciclib or gemcitabine
Use of strong CYP34A inhibitors which cannot be discontinued by the patient prior to trial initiation. The washout period of these drugs should be 5 half-lives
Progression on prior CDK4 inhibitor therapy
Phase 2 only: Prior gemcitabine-based chemotherapy
Presence of significant cardiac disease. Significant cardiac disease includes personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
Patients with interstitial lung disease (ILD)
Patients with gastrointestinal conditions that may affect the absorption of oral medications
Patients must not have received or be scheduled to receive radiation therapy within 7 days or less from gemcitabine administration
Patients must not have had major surgery within 14 days prior to randomization
What this trial measures
- Time course of blood thymidine kinase activity (TKa) (Phase 1 Part A)Baseline up to 2 years
Will be graphically evaluated: the change of blood TKa over time to facilitate a selection of regimen that has maximum decrease in blood TKa after end of abemaciclib (cell cycle arrest) and has maximum increase in blood TKa at time of gemcitabine injection. Descriptive statistics (mean, standard deviation) and graphical methods will be applied to examine the distribution of the data, error checking, and outlier identification. Since blood TKa and fluorothymidine F-18 (18F-FLT) positron emission tomography (PET) will be measured at baseline and multiple post treatment time points, if appropriate, linear mixed effect models for repeated measures analysis will be employed to assess its change over time. Appropriate transformation of the marker values will be used to satisfy the normality assumption of linear mixed effect model.
- Maximum tolerated dose (Phase I Part B)Up to 28 days
- Progression free survival (PFS) (phase II)From randomization to either disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) or death from any cause, up to 2 years
Will be estimated using the Kaplan-Meier method.