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Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02101593
Recruitment Status : Completed
First Posted : April 2, 2014
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):
Polaris Group

Brief Summary:
Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced Hepatocellular Carcinoma (HCC).

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: ADI-PEG 20 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of ADI PEG 20 Plus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)
Study Start Date : November 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ADI-PEG 20 Drug: ADI-PEG 20
Other Name: arginine deiminase formulated with polyethylene glycol

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability of ADI-PEG 20 in combination with sorafenib in advanced HCC [ Time Frame: course of study - 1 year expected ]

Information from the National Library of Medicine

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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:

  1. Prior diagnosis of HCC confirmed histologically.
  2. HCC tissue either from an archived specimen or from a new biopsy of sufficient amount and quality should be available for IHC determination of ASS status, and other biomarkers, to be performed retrospectively. Subjects with no tissue available would require a biopsy.
  3. No prior treatment with systemic chemotherapy (except as noted in exclusion criteria # 10).
  4. 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. Local therapies including chemoembolization do not count as prior systemic therapy.
  5. 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 B). 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.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix C).
  7. Expected survival of at least 3 months.
  8. Age ≥ 18 years.

Exclusion Criteria:

  1. Candidate for potential curative therapies (i.e., resection or transplantation).
  2. Prior allograft transplantation including liver transplantation.
  3. 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.
  4. Pregnancy or lactation.
  5. Expected non-compliance.
  6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV; Appendix D), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
  7. Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional therapies.
  8. Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02101593

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Polaris Group
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Principal Investigator: Ghassan Abou-Alfa, MD Memorial Sloan-Kettering Cancer Center (MSKCC)
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Responsible Party: Polaris Group Identifier: NCT02101593    
Other Study ID Numbers: POLARIS2013-005
First Posted: April 2, 2014    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Polaris Group:
argininosuccinate synthetase
arginine deiminase
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases