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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02082691
Recruitment Status : No longer available
First Posted : March 10, 2014
Last Update Posted : March 10, 2014
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Drug: G-202

Study Design

Study Type : 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

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.
Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082691

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

Responsible Party: Devalingam Mahalingam, Prinicipal Investigator, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02082691     History of Changes
Other Study ID Numbers: CTRC 13-0040
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014

Keywords provided by Devalingam Mahalingam, The University of Texas Health Science Center at San Antonio:

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases