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NCT02082691 Clinical Trial

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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT02082691
Other study ID # CTRC 13-0040
Secondary ID HSC20130391T [UT
Status No longer available
Phase N/A
First received March 6, 2014
Last updated March 6, 2014

Study information
Verified date March 2014
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Devalingam Mahalingam GenSpera, Inc.
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