Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
Eligible patients will be randomised to receive 36 mg/m2 of weekly ADI-PEG 20 or a placebo, in combination with pemetrexed (500mg/m2) and cisplatin (75mg/m2) which will be administered intravenously every three weeks.
Conditions
This trial is treating people with mesothelioma
Eligibility
Inclusion
- 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
- 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.
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Polaris Group
Scientific 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
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