An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies with HRAS Mutations.

Phase 2

Completed

• Conditions: advanced cancer; cancer with a specific genetic mutation; 10014713

• Registration Number: NL-OMON48820
• Lead Sponsor: Kura Oncology, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

- Subject is at least 18 years of age.
- Subject has a histologically or cytologically confirmed diagnosis of non-hematological malignancy for which there is no curative therapy available
- Subject has a tumor that carries a missense HRAS mutation according to a methodology approved by the Sponsor.
- Subject has measurable disease according to RECIST v1.1 and has relapsed (progressive disease) or is refractory to prior therapy

Exclusion Criteria

- Ongoing treatment with an anticancer agent not contemplated in this protocol.
- Prior treatment (at least 1 full treatment cycle) with an FTase inhibitor.
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Response assessments according to RECIST 1.1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Treatment-emergent adverse events (TEAE) and SAEs evaluated according to NCI<br /><br>CTCAE v.4.03</p><br>