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Ph 1 Study ADI-PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Polaris Group
Information provided by (Responsible Party):
Polaris Group Identifier:
First received: March 28, 2014
Last updated: April 3, 2017
Last verified: August 2016
Assessment of safety and tolerability of ADI-PEG 20 in combination with folinic acid (leucovorin), fluorouracil and oxaliplatin (FOLFOX) in advanced GI malignancies.

Condition Intervention Phase
Advanced Gastrointestinal (GI) Malignancies
Hepatocellular Carcinoma
Gastric Cancer
Colorectal Cancer
Drug: ADI-PEG 20
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase 1 Study of ADI PEG 20 Plus FOLFOX in Subjects With Advanced Gastrointestinal Malignancies

Resource links provided by NLM:

Further study details as provided by Polaris Group:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 148
Study Start Date: November 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADI-PEG 20 Drug: ADI-PEG 20
Other Name: arginine deiminase formulated with polyethylene glycol


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02102022

Contact: John Bomalaski, M.D. 858-452-6688 ext 114
Contact: Jessica Frick 858-452-6688 ext 133

United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: James Harding, MD         
Principal Investigator: James Harding, MD         
Tri-Service General Hospital Recruiting
Taipei, Taiwan
Contact: Yee Chao, MD         
Chang Gung Medical Foundation - Linkou Recruiting
Taoyuan, Taiwan
Contact: Tsai-Sheng Yang, MD         
Sponsors and Collaborators
Polaris Group
Principal Investigator: James Harding, MD Memorial Sloan-Kettering Cancer Center (MSKCC)
  More Information

Responsible Party: Polaris Group Identifier: NCT02102022     History of Changes
Other Study ID Numbers: POLARIS2013-001
Study First Received: March 28, 2014
Last Updated: April 3, 2017

Keywords provided by Polaris Group:
argininosuccinate synthetase
arginine deiminase

Additional relevant MeSH terms:
Colorectal Neoplasms
Carcinoma, Hepatocellular
Stomach Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Liver Diseases
Stomach Diseases processed this record on April 27, 2017