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Clinical Trial Summary

Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open


Clinical Trial Description

This Phase II study will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced, unresectable or metastatic, relapsed and/or refractory tumors that carry HRAS mutations and for whom there is no curative therapy available. Subjects with information available on tumor HRAS status previously generated are eligible. All subjects must consent to provide at least 10 tumor slides from a prior diagnostic biopsy for a retrospective testing of HRAS gene status at a central facility. Subjects will be enrolled into three nonrandomized cohorts: - Cohort 1: Malignant thyroid tumors with HRAS mutations (cohort is closed). - Cohort 2: Squamous Cell Carcinoma Head and Neck Cancer with HRAS mutations. - Cohort 3: Squamous Cell Carcinoma (SCC) with HRAS mutations other than HNSCC ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02383927
Study type Interventional
Source Kura Oncology, Inc.
Contact
Status Completed
Phase Phase 2
Start date March 2015
Completion date November 30, 2020

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