Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma

NCT ID: NCT02082691

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

Patient with advanced liver cancer (cancer that has spread to other parts of the body) continues to receive the study drug (G-202) even though patient no longer meets the criteria to be a part of the main treatment study. Patient's cancer responded well to receiving G-202 in the main study and will receive G-202 at the same dose given in the main study.

Conditions

Hepatocellular Carcinoma

Interventions

G-202

Patient will receive G-202 for 3 days in a row, followed by 25 days without taking G-202. This cycle will be repeated every 28 days. Patient will receive G-202 as long as his/her cancer does not grow and the investigational drug side effects are tolerable.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• History of hepatocellular carcinoma
• Participation in prior research study where G-202 was administered
• Tolerance of G-202 treatment
• Demonstration of stable disease

Exclusion Criteria

• Disease progression
• Occurrence of unacceptable toxicity

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GenSpera, Inc.

INDUSTRY

Sponsor Role: collaborator

Devalingam Mahalingam

OTHER

Sponsor Role: lead

Responsible Party

Devalingam Mahalingam

Prinicipal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Devalingam Mahalingam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Other Identifiers

HSC20130391T [UTHSCSA IRB]

Identifier Type: -

Identifier Source: secondary_id

CTRC 13-0040

Identifier Type: -

Identifier Source: org_study_id