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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary End Point of PFS

Secondary outcome measures

Secondary End Point of ORR (CR+PR)

Secondary End Point of Overall Survival (OS)

Secondary End Point of Safety and Tolerability

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

Find a Location

Who is running the clinical trial?

Polaris GroupLead Sponsor

24 Previous Clinical Trials

2,987 Total Patients Enrolled

John S BomalaskiStudy DirectorPolaris Group

3 Previous Clinical Trials

400 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are currently participating in this research?

"Affirmative. According to the data provided by clinicaltrials.gov, this medical trial is still actively looking for patients and was first posted on November 1st 2023 with its last edit being made on November 27th of that same year. The study requires 300 participants across one location."

Answered by AI

Are elderly individuals over 70 years old welcome to participate in this trial?

"According to the study's eligibility parameters, those hoping to be considered must lie between 18 and 99 years of age. There are 150 medical trials limited to younger participants and 386 options for senior citizens in need of treatment."

Answered by AI

Are there vacancies still available for participants in this investigation?

"According to clinicaltrials.gov, this investigation is currently recruiting participants; the trial was initially published on November 1st 2023 and most recently modified on November 27th of that year."

Answered by AI

Has the FDA authorized ADIGemDoc for use?

"According to our estimation, ADIGemDoc is classified as 'safe' on a scale of 1-3 due to Phase 3 trial results that demonstrate its efficacy and reliability."

Answered by AI

Is it feasible for me to join the research endeavor?

"This medical experiment is accepting 300 individuals aged 18 to 99 who have been diagnosed with soft tissue sarcoma. Furthermore, they must meet the criteria outlined in Appendixes A and B of this trial: Histologically or cytologically verified grade 2 or 3 LMS STS, confirmation of subtype (uterine/non-uterine), measurable disease per RECIST 1.1, prior treatment up to two systemic regimens including doxorubicin therapy more than one year ago in adjuvant/neoadjuvant setting; age over 18 years old; ECOG performance status less than 1 at enrollment; leukocytes"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

2023. "Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05712694.

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