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Enzyme Depletion

ADI-PEG 20 + Chemotherapy for Leiomyosarcoma

Phase 3

Recruiting

Research Sponsored by Polaris Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be standardly treated with Gem or GemDoc.

Measurable disease per RECIST 1.1 (Appendix A), defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up subjects will receive triplet combination treatment followed by weekly monotherapy adi-peg 20 or pbo (each cycle is 21 days). subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).

Awards & highlights

Pivotal Trial

Summary

This trial compares the effectiveness and safety of a new treatment for a type of cancer that has already had an existing treatment.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic Leiomyosarcoma (LMS), a type of soft tissue sarcoma, previously treated with an anthracycline. Participants must have measurable disease and good performance status, meaning they can carry out daily activities without significant limitations. They should not have had more than two systemic treatments but may have received Gemcitabine (Gem) or Docetaxel (Doc) over a year ago.

What is being tested?

The study is testing the effectiveness and safety of ADI-PEG 20 combined with chemotherapy drugs Gemcitabine and Docetaxel versus placebo plus these chemotherapies in patients with LMS who've already undergone some treatment. The goal is to see if ADI-PEG 20 can improve outcomes for these patients.

What are the potential side effects?

Possible side effects include those commonly associated with chemotherapy such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk or bleeding problems. Specific side effects related to ADI-PEG 20 are not detailed but could be similar to other enzyme-targeting therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My soft tissue sarcoma is confirmed to be grade 2 or 3 and treatable with specific chemotherapy.

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My cancer can be measured by scans or physical exam.

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I am older than 18 years.

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I have had up to 2 cancer treatments, one of which included doxorubicin.

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I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ subjects will receive triplet combination treatment followed by weekly monotherapy adi-peg 20 or pbo (each cycle is 21 days). subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~subjects will receive triplet combination treatment followed by weekly monotherapy adi-peg 20 or pbo (each cycle is 21 days). subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and subjects will receive triplet combination treatment followed by weekly monotherapy adi-peg 20 or pbo (each cycle is 21 days). subjects tolerating chemotherapy may continue chemotherapy beyond 8 cycles and up to 104 weeks (~2 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary End Point of PFS

Secondary study objectives

Secondary End Point of ORR (CR+PR)

Secondary End Point of Overall Survival (OS)

Secondary End Point of Safety and Tolerability

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ADIGemDocExperimental Treatment1 Intervention

ADI-PEG 20: 36 mg/m2 on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 600 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 60 mg/m2 on day 8 of each 21-day cycle

Group II: PBOGemDocPlacebo Group1 Intervention

Placebo: matched PBO on Day -7 of Cycle 1, and Days 1, 8, and 15 of each 21-day cycle Gemcitabine: 900 mg/m2 on days 1 and 8 of each 21-day cycle Docetaxel: 75 mg/m2 on day 8 of each 21-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADI PEG20

2019

Completed Phase 1

~10

0 / 5Eligibility criteria met