Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations

Thyroid Cancer Clinical Trial

Official title: An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations

Status Completed

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 ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• HRAS Mutant Tumor
• Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor
• Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
• Thyroid Cancer
• Thyroid Neoplasms

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