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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.
GenSpera, Inc.
Information provided by (Responsible Party):
Devalingam Mahalingam, The University of Texas Health Science Center at San Antonio Identifier:
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.

Condition Intervention
Hepatocellular Carcinoma
Drug: G-202

Study Type: Expanded Access     What is Expanded Access?
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

Resource links provided by NLM:

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Intervention Details:
    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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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
  Contacts and Locations
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 identifier: NCT02082691

Sponsors and Collaborators
Devalingam Mahalingam
GenSpera, Inc.
Principal Investigator: Devalingam Mahalingam, MD University of Texas Health Science Center San Antonio
  More Information

No publications provided

Responsible Party: Devalingam Mahalingam, Prinicipal Investigator, The University of Texas Health Science Center at San Antonio Identifier: NCT02082691     History of Changes
Other Study ID Numbers: CTRC 13-0040, HSC20130391T [UTHSCSA IRB]
Study First Received: March 6, 2014
Last Updated: March 6, 2014
Health Authority: 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:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on November 27, 2014