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Ph 2/3 Study in Subjects With MPM w/Low ASS 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

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 with low argininosuccinate synthetase 1 expression. 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.

Tracking Information
First Received DateMarch 5, 2016
Last Changed DateAugust 17, 2017
Start DateOctober 2016
Anticipated Primary Completion DateApril 2018
Primary Outcome Measures

Response Rate [Time Frame: approximately 18 months]

Secondary Outcome Measures

Progression Free Survival [Time Frame: approximately 18 months]

Descriptive Information
PhasePhase 2/Phase 3
Study TypeInterventional
Condition
  • Mesothelioma
Intervention
  • Drug: ADI-PEG 20 plus Pem Cis
  • Other: Placebo plus Pem Cis
Study Arms / Comparison Groups2 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment386
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Phuong Lee
Email: plee@polarispharma.com
Phone: 858-452-6688 x 188
Eligibility Criteria

Inclusion Criteria:

1. Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor

2. Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).

3. MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for study entry at study start, but tumor sample for ASS1 status is required. This study will employ an adaptive biomarker-driven design with an interim analysis to be conducted at the end of the phase 2 portion. The interim analysis will evaluate the treatment effect of ADI PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in the overall population (biphasic and sarcomatoid histology patients) and pre-defined subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus ASS1 deficiency may be required for the phase 3 portion of the study, pending the interim analysis. ASS1-deficiency, demonstrated on tissue specimen (cytospin samples are not acceptable), will be defined in the laboratory manual. If archived tissue is not sufficient or not available, then tissue must be obtained by biopsy.

4. Measurable disease as assessed by modified RECIST for MPM for thoracic disease (Appendix A) and RECIST 1.1 for extra-thoracic disease (Appendix B).

5. ECOG performance status of 0 - 1 (Appendix C).

6. Predicted life expectancy of at least 12 weeks.

Exclusion Criteria:

1. Radiotherapy (except for palliative reasons) the previous two weeks before.

2. Ongoing toxic manifestations of previous treatments.

3. Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).

4. Major thoracic or abdominal surgery from which the patient has not yet recovered.

5. Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.

6. Known to be serologically positive for human immunodeficiency virus (HIV). Testing to determine possible infection status is not required.

Administrative Information
NCTIDNCT02709512
Responsible Party,
SponsorPolaris Group
Verification DateNovember 2016
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