Clinical Trial 22695

• Overview

  Study Title:

  ADI-PEG 20 (Pegargiminase) or Placebo (PBO) plus Gemcitabine and Docetaxel in Previously Treated Subjects with Leiomyosarcoma (ARGSARC): A Randomized, Double-Blind, Multi-Center Phase 3 Trial

  Objective:

  Primary: The primary objective is to compare the primary endpoint of PFS in subjects treated with the arginine degrading enzyme ADI-PEG 20 plus Gem and Doc (ADIGemDoc) or PBO plus Gem and Doc (PBOGemDoc) in the 2nd or 3rd line setting using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by blinded independent central review committee (BICR). Secondary The secondary objectives are to compare ADIGemDoc versus PBOGemDoc with respect to: * Objective response rate (ORR) (complete response [CR] + partial response [PR]) * Overall survival (OS) * Safety and tolerability

• Treatments

  Therapies:

  Chemotherapy (NOS); Therapy (NOS)

  Medications:

  ADI-PEG 20 (); Gemzar (gemcitabine); Placebo (); Taxotere (docetaxel); docetaxel (); gemcitabine ()

• Inclusion Criteria

  Key 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 as defined in the protocol.
  • Previous treatment with up to 2 systemic regimens, including at least 1 systemic regimen containing doxorubicin.
  • Treatment greater than one year ago in the adjuvant/neoadjuvant setting with Gem or Doc is allowed.
  • 18 years of age or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.
  • Ability to understand and willingness to sign the informed consent form.
  • No concurrent investigational drug studies are allowed.
  • Subjects and their partners must be asked to use appropriate contraception.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key 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 other investigational agents.
  • Prior treatment with ADI-PEG 20, Gem or Doc. Patients treated greater than one year ago in the adjuvant/neoadjuvant setting with Gem or Doc are allowed to be enrolled.
  • 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.
  • Grade 2 or higher neuropathy.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
  • Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with the study treatment. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  • Currently receiving other immunosuppressive agents.
  • Subjects under guardianship, curatorship, under legal protection or deprived of liberty by an administrative or judicial decision.
  • Other exclusion criteria may apply.

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