This study is in progress, not accepting new patients

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

a study on Mesothelioma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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. 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 Mesotheliomato Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

Keywords

Mesothelioma Malignant Pleural Mesothelioma Mesothelioma, Malignant 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

  • 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

You CAN'T join if...

  • 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.

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Polaris Group
ID
NCT02709512
Phase
Phase 2/3 Mesothelioma Research Study
Study Type
Interventional
Participants
Expecting 386 study participants
Last Updated