Expanded Access to Tipifarnib

Sponsor
Kura Oncology, Inc. (Industry)
Overall Status
Available
CT.gov ID
NCT04809233
Collaborator
(none)

Study Details

Study Description

Brief Summary

This single-patient Expanded Access / Compassionate Use program is designed to provide access to single-agent tipifarnib for individual eligible adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL) prior to approval by the local regulatory agency.

Importantly , expanded access for Tipifarnib is only available in the United States.

A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Expanded Access

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion/Exclusion Criteria:

    Suffer from HRAS-mutant carcinomas or peripheral T Cell Lymphoma (PTCL)

    Adult, ages 18+

    Have exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.

    Are ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.

    Meets any other pertinent medical criteria for access to the investigational drug, as established by the Kura Oncology clinical or medically responsible individual

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kura Oncology, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kura Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT04809233
    Other Study ID Numbers:
    • Expanded Access to Tipifarnib
    First Posted:
    Mar 22, 2021
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2022