Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
G-202
Sponsored by
About this trial
This is an expanded access trial for Hepatocellular Carcinoma focused on measuring G-202, Hepatocellular
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02082691
First Posted
March 6, 2014
Last Updated
March 6, 2014
Sponsor
Devalingam Mahalingam
Collaborators
GenSpera, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02082691
Brief Title
Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma
Official Title
Single Patient IND: Continued Administration of G-202 to a Patient With Advanced Hepatocellular Carcinoma Previously Treated With G-202 and Receiving Clinical Benefit
Study Type
Expanded Access
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Devalingam Mahalingam
Collaborators
GenSpera, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
G-202, Hepatocellular
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
G-202
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devalingam Mahalingam, MD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma
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