Ph 2/3 Study in Subjects With MPM to Assess ADI-PEG 20 With Pemetrexed and Cisplatin
- Interventional
- Active
- NCT02709512
Contact Information
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)
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.