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

NCT02101593 | Completed Phase 1

• 1 other identifier: POLARIS2013-005
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

argininosuccinate synthetase; arginine; arginine deiminase

Outcome Measures

Primary Outcomes (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

  course of study - 1 year expected

Study Arms (1)

ADI-PEG 20

EXPERIMENTAL

Drug: ADI-PEG 20

Interventions

ADI-PEG 20 DRUG

Also known as: arginine deiminase formulated with polyethylene glycol

ADI-PEG 20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior diagnosis of HCC confirmed histologically.
• 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.

You may not qualify if:

• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Appendix C).
• Expected survival of at least 3 months.
• Age ≥ 18 years.
• Candidate for potential curative therapies (i.e., resection or transplantation).
• Prior allograft transplantation including liver transplantation.
• 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.
• Pregnancy or lactation.
• Expected non-compliance.
• 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.
• Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional therapies.
• 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.

Sponsors & Collaborators

• Polaris Group: lead

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

ADI PEG20; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ghassan Abou-Alfa, MD

  Memorial Sloan-Kettering Cancer Center (MSKCC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 2, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

US (2)