Trial record 2 of 2 for:
Hepatocellular Carcinoma GenSpera
Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma
Expanded access is no longer available for this treatment.
Information provided by (Responsible Party):
Devalingam Mahalingam, The University of Texas Health Science Center at San Antonio
First received: March 6, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
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.
What is Expanded Access?
||Single Patient IND: Continued Administration of G-202 to a Patient With Advanced Hepatocellular Carcinoma Previously Treated With G-202 and Receiving Clinical Benefit
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
- History of hepatocellular carcinoma
- Participation in prior research study where G-202 was administered
- Tolerance of G-202 treatment
- Demonstration of stable disease
- Disease progression
- Occurrence of unacceptable toxicity
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02082691
||Devalingam Mahalingam, MD
||University of Texas Health Science Center San Antonio
No publications provided
||Devalingam Mahalingam, Prinicipal Investigator, The University of Texas Health Science Center at San Antonio
History of Changes
|Other Study ID Numbers:
||CTRC 13-0040, HSC20130391T [UTHSCSA IRB]
|Study First Received:
||March 6, 2014
||March 6, 2014
||United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by The University of Texas Health Science Center at San Antonio:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases