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

Trial Summary

What is the purpose of this trial?

This phase 1/2 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 DNA 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.

Research Team

Elise F Nassif

Principal Investigator

University of Texas MD Anderson Cancer Center LAO

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

Group I: Phase I Part B (abemaciclib, gemcitabine) Experimental Treatment 5 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 5 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 5 Interventions

Patients receive abemaciclib PO BID on days 1-5 and 14-18 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 on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+