Abemaciclib + Gemcitabine for Soft Tissue Sarcoma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Strong CYP34A inhibitors

Disqualifiers: Cardiac disease, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safest and most effective dose of abemaciclib, a cancer treatment, when combined with gemcitabine for soft tissue sarcoma, a cancer that can spread to other parts of the body. It compares this new combination to the usual treatment of gemcitabine with docetaxel. Suitable participants include those with advanced or metastatic soft tissue sarcoma, leiomyosarcoma, or dedifferentiated liposarcoma who have previously undergone treatment. The goal is to assess whether the new combination can better manage the disease and slow its progression. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot use strong CYP34A inhibitors unless you can stop them before starting the trial. If you are on any investigational drugs, you must stop them at least 30 days before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining abemaciclib with gemcitabine might be safe and beneficial for individuals with advanced soft tissue sarcoma. Earlier studies found that this combination can kill cancer cells and inhibit their growth.

While abemaciclib is still under investigation for this specific use, it is already approved for other conditions, indicating it is generally well-tolerated. Studies have not identified any serious safety issues with this combination. However, as with any treatment, side effects may occur. Discuss these with a doctor when considering participation in a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about abemaciclib combined with gemcitabine for soft tissue sarcoma because this combo targets cancer cells in a unique way. Abemaciclib is a CDK4/6 inhibitor that disrupts cancer cell division, a different approach compared to standard chemotherapy options like doxorubicin, which directly attack rapidly dividing cells. Additionally, this trial explores different dosing schedules and combines abemaciclib with gemcitabine, a chemotherapy agent, to potentially enhance effectiveness and minimize side effects. This innovative strategy could offer new hope for patients by improving outcomes and providing an alternative when traditional treatments might not suffice.

What evidence suggests that this trial's treatments could be effective for soft tissue sarcoma?

This trial will evaluate the combination of abemaciclib and gemcitabine for treating advanced or spreading soft tissue sarcoma. Studies have shown that this combination can help treat these conditions by killing cancer cells and preventing them from repairing their DNA, potentially slowing or stopping tumor spread. Participants in this trial may receive abemaciclib, which blocks proteins that help cancer cells grow, alongside gemcitabine, which interferes with the DNA of cancer cells, making it harder for them to multiply. Early findings suggest this combination might outperform the usual treatment with gemcitabine and docetaxel, offering hope for better outcomes for patients with these types of sarcomas. ^{2 3 4 5 6}

Who Is on the Research Team?

Elise F Nassif

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic soft tissue sarcoma, including leiomyosarcoma and dedifferentiated liposarcoma. Participants must have had prior therapy (except gemcitabine for phase 2), measurable tumor presence, intact Rb gene expression in tumors, and meet specific health criteria like adequate blood counts and kidney function.

Inclusion Criteria

My white blood cell count is above 1,200 cells per microliter.

I have advanced soft tissue sarcoma and have had at least one standard treatment.

I can take care of myself but might not be able to do heavy physical work.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase 1 Treatment

Patients receive abemaciclib and gemcitabine in different cohorts to determine the recommended phase 2 dose

Up to 2 years

Multiple visits per cycle (in-person)

Phase 2 Treatment

Patients receive abemaciclib and gemcitabine or gemcitabine and docetaxel, with potential crossover upon disease progression

Up to 2 years

Multiple visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months for up to 2 years

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abemaciclib

Trial Overview

The trial is testing the safety and effectiveness of adding abemaciclib to the usual chemotherapy treatment with gemcitabine versus the standard combination of gemcitabine with docetaxel. It aims to find out if this new combo can better slow down or stop cancer growth in patients.

How Is the Trial Designed?

Group I: Phase I Part B (abemaciclib, gemcitabine) Experimental Treatment 6 Interventions

Patients receive the selected treatment schedule, Cohort 1 or Cohort 2, as above. Cycles repeat every 21 or 28 days for up to 2 years of total treatment in the absence of disease progression or unacceptable toxicity.

Group II: Phase I Part A Cohort II (abemaciclib, gemcitabine) Experimental Treatment 6 Interventions

Patients receive abemaciclib PO BID on days 1-7 and gemcitabine IV over 90 minutes on day 10 of each cycle. Cycles repeat every 21 days for up to 2 years of total treatment in the absence of disease progression or unacceptable toxicity. Patients may change to Phase 1 Part B treatment once the recommended schedule is determined. Patients also receive 18F-FLT IV and undergo PET/CT during screening and on study. Additionally, patients undergo blood sample collection during screening and on study.

Group III: Phase I Part A Cohort I (abemaciclib, gemcitabine) Experimental Treatment 6 Interventions

Patients receive abemaciclib PO BID on days 1-5 and 15-19 of each cycle and gemcitabine IV over 90 minutes on days 8 and 22 of each cycle. Cycles repeat every 28 days for up to 2 years of total treatment in the absence of disease progression or unacceptable toxicity. Patients may change to Phase 1 Part B treatment once the recommended schedule is determined. Patients also receive 18F-FLT IV and undergo PET/CT during screening and on study. Additionally, patients undergo blood sample collection during screening and on study.

Group IV: Phase 2 Arm A (abemaciclib, gemcitabine) Experimental Treatment 4 Interventions

Patients receive abemaciclib PO BID and gemcitabine IV on the schedule determined in phase 1 of the trial. Cycles repeat every 21 or 28 days for up to 2 years of total treatment in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients may cross over to arm B. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy on study.

Group V: Phase 2 Arm B (gemcitabine, docetaxel) Active Control 4 Interventions

Patients receive gemcitabine IV over 90 minutes on days 1 and 8 of each cycle and docetaxel IV over 60 minutes on day 8 of each cycle. Cycles repeat every 21 days for up to 2 years of total treatment in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients may cross over to arm A. Patients undergo blood sample collection throughout the study. Patients also undergo tumor biopsy during screening and optionally on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1.

ascopubs.org

ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.TPS11583

Phase I/II study to evaluate the feasibility and efficacy of ...

Sequential administration of abemaciclib followed by gemcitabine enhances apoptosis, impairs DNA repair mechanisms, and induces sustained cell cycle arrest.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06498648?tab=table

Testing the Addition of an Anti-cancer Drug, Abemaciclib ...

Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11898467/

Systemic Treatment in Soft Tissue Sarcomas

Newer trials have reported a moderately improved median OS for doxorubicin monotherapy, showing 17.6 months in the GeDDiS trial [18], 16.9 ...

4.

mdanderson.org

mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2024-0029.html

NCI10657: Phase I/II study to evaluate the feasibility and ...

Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or metastatic ...

5.

mdpi.com

mdpi.com/2072-6694/17/1/10

Novel Therapeutics in Soft Tissue Sarcoma

Abemaciclib, another CDK4/6 inhibitor in a dose and schedule of 200 mg by mouth twice daily continuously, resulted in a median PFS of 30.4 (95% CI, 28.9-NE) ...

6.

withpower.com

withpower.com/trial/abemaciclib-gemcitabine-for-soft-tissue-sarcoma-8a8c7

Abemaciclib + Gemcitabine for Soft Tissue Sarcoma

Giving abemaciclib with gemcitabine may be safe and effective when compared to treatment with gemcitabine and docetaxel for patients with advanced or ...