Study to test ADIPEG20 in patients with mesothelioma and NSCLC V 02
Research type
Research Study
Full title
Phase 1 Study in Subjects with Tumors Requiring Arginine to Assess ADI-PEG 20 with Pemetrexed and Cisplatin (ADIPemCis) (TRAP Study)
IRAS ID
150145
Contact name
Peter Szlosarek
Contact email
Sponsor organisation
Polaris Pharmaceuticals
Eudract number
2013-005330-38
Clinicaltrials.gov Identifier
Research summary
This study is researching the safety and tolerability of adding ADI-PEG 20 to the standard of care, pemetrexed and cisplatin. Another aim is to find the best doses of the three drugs when given as a combination. There may be no potential benefit to the participants but there could be benefit to future patients by improving the efficacy of the standard of care with the addition of ADI-PEG 20. The therapeutic area under investigation is mesothelioma (pleural and advanced) and non-squamous non-small cell lung cancer.The study drug is ADI-PEG 20 a recombinant protein. Treatment naïve patients with advanced malignant pleural mesothelioma, advanced peritoneal mesothelioma and non-squamous non-small cell lung cancer(stage IIIB/IV) who have demonstrated ASS1 deficiency on tumor tissue. Tumors that are deficient in ASS seem to have the best respond to ADI-PEG 20. The study sites are Bart’s Cancer Institute, King’s college and Cambridge University Hospital. Study is anticipated to last for about 1.5 years. Treatment period on the combination therapy is 18 weeks and while on treatment participants will have weekly visits for blood draws, study drug administration and routine care and CT scans will be done every 6-8 weeks.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0090
Date of REC Opinion
17 Apr 2014
REC opinion
Further Information Favourable Opinion