Expanded Access to Tipifarnib (Kuraoncology)
Requests for single patient expanded access to tipifarnib may be considered for adult patients with HRAS mutations or peripheral T Cell Lymphoma (PTCL).
To request access, use Responsible Party contact information provided in this record.
Expanded access for tipifarnib is only available in the United States.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Expanded Access Type
Expanded Access Type
- Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
- Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
- Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
- Individual Patients
Contacts and Locations
Study Contact
Study Contact
- Name: Kura Medical Information
- Phone Number: 844-KURAONC (844-587-2662)
- Email: medinfo@kuraoncology.com
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion/Exclusion Criteria:
Diagnosed with HRAS mutations 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.
Is 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
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Expanded Access to Tipifarnib
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