Is NCT06498648 recruiting in Houston, TX?

Yes, NCT06498648 is currently recruiting participants at its Houston, TX location. This advanced dedifferentiated liposarcoma clinical trial is actively enrolling qualified participants.

Is participation in this Houston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Advanced Dedifferentiated Liposarcoma Clinical Trial in Houston, TX

Q: How do I join the advanced dedifferentiated liposarcoma clinical trial in Houston?

To join this clinical trial in Houston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Advanced Dedifferentiated Liposarcoma Study in Houston

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.

Sponsor: National Cancer Institute (NCI)

Who Can Participate

Inclusion Criteria

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 Criteria

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Houston?

Yes, this clinical trial (NCT06498648) has an active research site in Houston, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Advanced Dedifferentiated Liposarcoma Treatment Options in Houston, TX

If you're searching for advanced dedifferentiated liposarcoma treatment options in Houston, TX, this clinical trial (NCT06498648) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced advanced dedifferentiated liposarcoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all advanced dedifferentiated liposarcoma clinical trials near you to find additional studies recruiting in your area.

Advanced Dedifferentiated Liposarcoma Clinical Trial in Houston, TX

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