Clinical Trials /

Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

NCT02709512

Description:

This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.

Related Conditions:
  • Pleural Biphasic Mesothelioma
  • Pleural Mesothelioma, Sarcomatoid Type
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

URL:

https://clinicaltrials.gov/show/NCT02709512

Trial Eligibility

Document

Title

  • Brief Title: Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
  • Official Title: Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

Clinical Trial IDs

  • ORG STUDY ID: POLARIS2015-003
  • NCT ID: NCT02709512

Conditions

  • Mesothelioma

Interventions

DrugSynonymsArms
ADI-PEG 20 plus Pem CisPemetrexed, CisplatinDrug: ADI-PEG 20 plus Pem Cis

Purpose

This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma. Malignant pleural mesothelioma have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the malignant pleural mesothelioma cells will starve and die.

Trial Arms

NameTypeDescriptionInterventions
Drug: ADI-PEG 20 plus Pem CisExperimentalDose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous
  • ADI-PEG 20 plus Pem Cis
Drug: Placebo plus Pem CisPlacebo ComparatorDose: 36 mg/m2 given weekly Route of Administration: Intramuscular (IM) Duration : Course of Study In Combination With: Pemetrexed Dose: 500 mg/m2 every 3 weeks Route of Administration: Intravenous Cisplatin Dose: 75 mg/m2 every 3 weeks Route of Administration: Intravenous

    Eligibility Criteria

            Inclusion Criteria:

          -  Histologically proven unresectable MPM of biphasic or sarcomatoid histology

          -  Naïve to chemotherapy or immunotherapy

          -  ECOG PS 0-1

          -  Expected survival of at least 3 months

          -  Age 18 years or over (there is no upper age limit)

          -  Measurable disease by modified RECIST criteria for MPM for local pleural disease and
             RECIST 1.1 criteria for metastatic lesions

          -  Written (signed and dated) informed consent and must be capable of co-operating with
             treatment and follow up

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

          -  Radiotherapy (except for palliative reasons) in the previous two weeks before study
             treatment

          -  History of unstable cardiac disease

          -  Ongoing toxic manifestations of previous treatments

          -  Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month
             post radiotherapy or surgery)

          -  Major thoracic or abdominal surgery from which the patient has not yet recovered.
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Response Rate
    Time Frame:approximately 18 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Progression Free Survival
    Time Frame:approximately 18 months
    Safety Issue:
    Description:

    Details

    Phase:Phase 2/Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Polaris Group

    Trial Keywords

    • Malignant Pleural Mesothelioma

    Last Updated

    March 9, 2021