RecruitingPhase 3

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

United States300 participantsStarted 2023-11-29

Plain-language summary

To compare the efficacy and safety in subjects with advanced or metastatic LMS previously treated with an anthracycline.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically confirmed, grade 2 or 3, LMS STS that would be standardly treated with Gem or GemDoc.
✓. Determination of LMS subtype: uterine or non-uterine.
✓. 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.
✓. Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin.
✓. Treatment \> one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is allowed.
✓. Age \>18 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of \< 1 at enrollment (Appendix B).
✓. Leukocytes ≥ 3,000/mcL.

Exclusion criteria

✕. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of current diagnosis.
✕. Currently receiving chemotherapy, immunotherapy, interferon, radiation therapy or other investigational agents. Note: Chemotherapy agent washout period is 5 half-lives prior to randomization. Radiation washout period is 7 days prior to randomization.
✕. Prior treatment with ADI-PEG 20, Gem or Doc. Patients treated \> one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
✕. Prior pelvic radiation.
✕. Known brain metastases. Such patients must be excluded from this trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ADI-PEG 20, Gem, Doc, polysorbate 80, pegylated compounds, or other agents used in this study.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
✕. History of seizure disorder not related to underlying cancer.

What they're measuring

Primary End Point of PFS

Timeframe: 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).

Trial details

NCT IDNCT05712694

SponsorPolaris Group

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Mirla Langlois

858-452-6688 mlanglois@polarispharma.com

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