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

Primary Purpose

Hepatocellular Carcinoma

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
G-202
Sponsored by
Devalingam Mahalingam
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Hepatocellular Carcinoma focused on measuring G-202, Hepatocellular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2014
    Last Updated
    March 6, 2014
    Sponsor
    Devalingam Mahalingam
    Collaborators
    GenSpera, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02082691
    Brief Title
    Continued Administration of G-202 for One Patient With Advanced Hepatocellular Carcinoma
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Devalingam Mahalingam
    Collaborators
    GenSpera, Inc.

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma
    Keywords
    G-202, Hepatocellular

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    G-202
    Intervention Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Devalingam Mahalingam, MD
    Organizational Affiliation
    University of Texas Health Science Center San Antonio
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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