Ph 2/3 Study in Subjects With MPM w/Low ASS 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

a study on Mesothelioma

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Thierry Jahan

Description

Summary

This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with malignant pleural mesothelioma with low argininosuccinate synthetase 1 expression. 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.

Official Title

Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

Keywords

Mesothelioma Malignant Pleural Mesothelioma with Low Argininosuccinate Synthetase 1 Expression Cisplatin Pemetrexed ADI-PEG 20 plus Pem Cis Drug: ADI-PEG 20 plus Pem Cis

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor
  2. Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).
  3. MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for study entry at study start, but tumor sample for ASS1 status is required. This study will employ an adaptive biomarker-driven design with an interim analysis to be conducted at the end of the phase 2 portion. The interim analysis will evaluate the treatment effect of ADI PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in the overall population (biphasic and sarcomatoid histology patients)and pre-defined subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus ASS1 deficiency may be required for the phase 3 portion of the study, pending the interim analysis. ASS1-deficiency, demonstrated on tissue specimen(cytospin samples are not acceptable), will be defined in the laboratory manual. If archived tissue is not sufficient or not available, then tissue must be obtained by biopsy.
  4. Measurable disease as assessed by modified RECIST for MPM for thoracic disease(Appendix A) and RECIST 1.1 for extra-thoracic disease (Appendix B).
  5. ECOG performance status of 0 - 1 (Appendix C).
  6. Predicted life expectancy of at least 12 weeks.

You CAN'T join if...

  1. Radiotherapy (except for palliative reasons) the previous two weeks before.
  2. Ongoing toxic manifestations of previous treatments.
  3. Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).
  4. Major thoracic or abdominal surgery from which the patient has not yet recovered.
  5. Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.
  6. Known to be serologically positive for human immunodeficiency virus (HIV). Testing to determine possible infection status is not required.

Locations

  • University of California San Francisco Helen Diller Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • UCLA Hematology & Oncology - Santa Monica accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Polaris Group
ID
NCT02709512
Phase
Phase 2/3
Lead Scientist
Thierry Jahan
Study Type
Interventional
Last Updated