We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02082691
First Posted: March 10, 2014
Last Update Posted: March 10, 2014
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.
Collaborator:
GenSpera, Inc.
Information provided by (Responsible Party):
Devalingam Mahalingam, The University of Texas Health Science Center at San Antonio
  Purpose
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

Further study details as provided by Devalingam Mahalingam, 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  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.
Investigators
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
HSC20130391T [UTHSCSA IRB]
First Submitted: March 6, 2014
First Posted: March 10, 2014
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:
G-202
Hepatocellular

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