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)
Brief 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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Response Rate
Secondary Outcome
Progression Free Survival
Condition
Mesothelioma
Intervention
ADI-PEG 20 plus Pem Cis
Study Arms / Comparison Groups
Drug: ADI-PEG 20 plus Pem Cis
Description: Dose: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
386
Start Date
August 1, 2017
Completion Date
June 2021
Primary Completion Date
October 2020
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
John S Bomalaski, MD, 858-452-6688, [email protected]
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02709512
Organization ID
POLARIS2015-003
Responsible Party
Sponsor
Study Sponsor
Polaris Group
Study Sponsor
John S Bomalaski, MD, Study Director, Polaris Group
Verification Date
August 2020