Clinical Trials /

Ph 1-2 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced GI Malignancies Focusing on Hepatocellular Carcinoma

NCT02102022

Description:

Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Ph 1 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies
  • Official Title: Phase 1 Study of ADI PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies

Clinical Trial IDs

  • ORG STUDY ID: POLARIS2013-001
  • NCT ID: NCT02102022

Conditions

  • Advanced Gastrointestinal (GI) Malignancies
  • Hepatocellular Carcinoma
  • Gastric Cancer
  • Colorectal Cancer

Interventions

DrugSynonymsArms
ADI-PEG 20arginine deiminase formulated with polyethylene glycolADI-PEG 20

Purpose

Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.

Trial Arms

NameTypeDescriptionInterventions
ADI-PEG 20Experimental
  • ADI-PEG 20

Eligibility Criteria

        Inclusion Criteria:

        For Advanced GI Malignancies (Dose Escalation and MTD Cohorts):

          1. Advanced histologically proven GI cancer.

          2. First line or progressive disease if already treated with any form of therapy,
             including but not limited to chemotherapy, radiotherapy, local therapy, surgery or
             immuno-therapy. Patients with HCC who failed sorafenib, with documented PD or AEs
             that resulted in discontinuance of that agent. Patients with pancreatic cancer (dose
             escalation only) who have progressed following a gemcitabine based regimen. Subjects
             failing prior platinum containing regimens are eligible. Gastric cancer subjects that
             express tumor HER-2 amplification must be treated with trastuzumab prior to
             enrollment, unless trastuzumab is not available for those indications in a particular
             country.

          3. Measurable disease using RECIST 1.1 criteria (Appendix A). At least 1 measurable
             lesion must be present. Subjects who have received local-regional therapy such as
             (but not limited to) chemoembolization, embolization, cryoablation, hepatic artery
             therapy, percutaneous ethanol injection, radiation therapy, radiofrequency ablation
             or surgery are eligible, provided that they have either a target lesion which has not
             been treated with local therapy and/or the target lesion(s) within the field of the
             local regional therapy has shown an increase of ≥ 20% in size. Local-regional therapy
             must be completed at least 4 weeks prior to the baseline CT scan.

          4. ECOG performance status of 0 - 1.

          5. Expected survival of at least 3 months.

        For HCC (Dose Escalation and MTD Expansion):

        19. Prior treatment with sorafenib, with documented PD or AEs that resulted in
        discontinuance of that agent. Patient may have been treated with other lines off therapy
        as well excluding ADI-PEG 20.

        20. Cirrhotic status of Child-Pugh grade A. Child-Pugh status should be determined based
        on clinical findings and laboratory data during the screening period (Appendix C).
        Subjects on Coumadin anti-coagulants are to receive only 1 point for their INR status.

        21. Serum albumin level ≥ 2.8 g/dl. 22. Prothrombin time (PT)-international normalized
        ratio (INR): PT <6 seconds above control or INR <1.7. Subjects on Coumadin anti-coagulants
        are to receive only 1 point for their INR status.

        23. Subjects with active hepatitis B or C on anti-viremic compounds may remain on such
        treatment, except for interferon.

        Exclusion Criteria:

          1. Serious infection requiring treatment with systemically administered antibiotics at
             the time of study entrance, or an infection requiring systemic antibiotic therapy
             within 7 days prior to the first dose of study treatment.

          2. Pregnancy or lactation.

          3. Expected non-compliance.

          4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure (New York Heart Association Class III
             or IV), cardiac arrhythmia, or psychiatric illness, social situations that would
             limit compliance with study requirements.

          5. Subjects who have had any anticancer treatment prior to entering the study and have
             not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or deemed irreversible
             from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a
             safety risk by the Sponsor and investigator may be allowed upon agreement with both.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.
Time Frame:course of study - 1 year expected
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Polaris Group

Trial Keywords

  • argininosuccinate synthetase
  • arginine
  • arginine deiminase

Last Updated

April 3, 2017