Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

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Brief Title

Ph 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin

Official Title

Phase 1 Study in Subjects With Tumors Requiring Arginine to Assess ADI-PEG 20 With Pemetrexed and Cisplatin (ADIPemCis) (TRAP Study)

Brief Summary

      A study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme in
      patients with histologically proven advanced malignant pleural mesothelioma (MPM), advanced
      peritoneal mesothelioma (in dose escalation cohort only), non-squamous non-small cell lung
      carcinoma stage IIIB/IV (NSCLC), metastatic uveal melanoma, hepatocellular carcinoma (HCC),
      glioma and sarcomatoid cancers
    

Detailed Description

      Weekly ADI-PEG 20 will be cohort dose escalated (18, 27 and 36 mg/m2), with pemetrexed 500
      mg/m2 and cisplatin 75 mg/m2 both given every 3 weeks. Subjects may receive a maximum of 6,
      3-week cycles of ADIPemCis for a total of 18 weeks of treatment. Subjects with NSCLC may
      receive 4 to 6, 3-week cycles as per local institutional policy. Those subjects completing
      ADIPemCis treatment may continue on ADI-PEG 20 monotherapy if they have SD or better.
      Subjects with NSCLC may continue to receive pemetrexed as per local institutional policy
      along with ADI-PEG 20 and/or continue on ADI-PEG 20 monotherapy after pemetrexed is also
      discontinued.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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.

Secondary Outcome

 Determine the MTD of ADI-PEG 20 in combination with pemetrexed and cisplatin

Condition

Pleural Mesothelioma Malignant Advanced

Intervention

ADI-PEG 20

Study Arms / Comparison Groups

 ADI-PEG 20
Description:  Arginine deiminase formulated with polyethylene glycol

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

85

Start Date

April 23, 2014

Completion Date

June 2020

Primary Completion Date

August 15, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. 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.

          2. 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.

          3. 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

          4. ECOG performance status of 0 - 1

          5. Predicted life expectancy of at least 12 weeks.

        Exclusion Criteria:

          1. Radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy
             (except for uveal melanoma) the previous four weeks before study treatment.

          2. Ongoing toxic manifestations of previous treatments.

          3. 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).

          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 to
             the first dose of study treatment.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Peter Szlosarek, MD, PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02029690

Organization ID

POLARIS2013-006


Responsible Party

Sponsor

Study Sponsor

Polaris Group


Study Sponsor

Peter Szlosarek, MD, PhD, Principal Investigator, Barts Cancer Institute


Verification Date

March 2019