Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (TRAP)
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ClinicalTrials.gov Identifier: NCT02029690 |
Recruitment Status :
Terminated
First Posted : January 8, 2014
Last Update Posted : September 25, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pleural Mesothelioma Malignant Advanced Peritoneal Mesothelioma Malignant Advanced Non-squamous Non-small Cell Lung Carcinoma Uveal Melanoma Hepatocellular Carcinoma Glioma Sarcomatoid Carcinoma | Drug: ADI-PEG 20 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ADIPemCis) (TRAP Study) |
Actual Study Start Date : | April 23, 2014 |
Actual Primary Completion Date : | August 15, 2018 |
Actual Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
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Experimental: ADI-PEG 20
Arginine deiminase formulated with polyethylene glycol
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Drug: ADI-PEG 20 |
- Define initial estimates of efficacy, measured by RECIST 1.1 criteria for non-squamous NSCLC, advanced peritoneal mesothelioma, metastatic uveal melanoma, HCC, glioma and sarcomatoid cancers for ADI-PEG 20 in combination with pemetrexed and cisplatin. [ Time Frame: 18 weeks ]
- Define initial estimates of efficacy, measured by modified RECIST criteria for advanced MPM [ Time Frame: 18 weeks ]
- Determine the MTD of ADI-PEG 20 in combination with pemetrexed and cisplatin [ Time Frame: 18 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven advanced MPM, advanced peritoneal mesothelioma (for dose escalation cohort only) or non-squamous NSCLC (stage IIIB/IV) who have not been treated with prior chemotherapy or immunotherapy, except that NSCLC subjects with EGFR mutant or ALK positive must have had an EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor and progressed or been shown to be intolerant of therapy prior to enrolling in this trial, if such ALK inhibitor and EGFR targeted therapy are approved and available in the country in which patients are being enrolled OR Histologically proven metastatic uveal melanoma who have not been treated with prior chemotherapy (MTD cohort only), OR Histologically proven HCC who have failed (PD and/or side effects-been intolerant of) treatment with sorafenib. Failure is defined as having progressed radiographically on, or been intolerant to prior systemic therapy. Intolerance is defined as discontinuation due to an AE(s) on prior systemic therapy that was unacceptable to the treating physician and / or patient, with or without dose interruption and modification. Failure requires at least 14 days of treatment with sorafenib, except for a subject that has had a severe allergic reaction to sorafenib at any time, even less than 14 days of treatment with sorafenib and thus it would be imprudent to re-challenge them with that agent. Cirrhotic status of Child-Pugh grade A-B7 must be present. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix E). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.", OR Histologically proven high-grade glioma who have failed (PD and/or side effects) treatment with radiotherapy ± temozolomide, OR Sarcomatoid cancer of any line.
- ASS1 deficiency (defined as ≤50% ASS expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (IHC). For subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. A new tissue specimen obtained after most recent chemotherapy is not required. Thus ASS1 deficiency is required for entrance into the study. If tissue is not available to determine ASS1 deficiency, then tissue must be obtained by biopsy to determine ASS1 status.
- Measurable disease as assessed by modified RECIST for MPM and by RECIST 1.1 criteria for peritoneal mesothelioma, NSCLC, uveal melanoma, HCC, glioma and sarcomatoid carcinoma
- ECOG performance status of 0 - 1
- Predicted life expectancy of at least 12 weeks.
Exclusion Criteria:
- Radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment.
- Ongoing toxic manifestations of previous treatments.
- Symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, NSCLC, uveal melanoma excludes subjects with HCC or glioma).
- Major thoracic or abdominal surgery from which the patient has not yet recovered.
- Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029690
United States, Minnesota | |
Mayo Clinic Rochester | |
Rochester, Minnesota, United States, 55902 | |
United Kingdom | |
Centre for Experimental Cancer Medicine (CECM) | |
London, England, United Kingdom, EC1M 6BQ | |
Cambridge Hospital | |
Cambridge, United Kingdom, CB2 0QQ | |
Guys Hospital | |
London, United Kingdom, SE1 7EH |
Principal Investigator: | Peter Szlosarek, MD, PhD | Barts Cancer Institute |
Responsible Party: | Polaris Group |
ClinicalTrials.gov Identifier: | NCT02029690 |
Other Study ID Numbers: |
POLARIS2013-006 |
First Posted: | January 8, 2014 Key Record Dates |
Last Update Posted: | September 25, 2020 |
Last Verified: | March 2019 |
argininosuccinate synthetase arginine arginine deiminase |
Carcinoma Mesothelioma Mesothelioma, Malignant Lung Neoplasms Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
Adenoma Neoplasms, Mesothelial Respiratory Tract Neoplasms Thoracic Neoplasms Pleural Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |