NCT02383927

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Kura Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 2: Squamous Cell Carcinoma Head and Neck Cancer with HRAS mutations. * Cohort 3: Squamous Cell Carcinoma (SCC) with HRAS mutations other than HNSCC.

Conditions

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

Interventions

Type	Name	Description
DRUG	Tipifarnib	FTase inhibitor

Timeline

• Start date: 2015-05-13
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2015-03-10
• Last updated: 2024-07-11
• Results posted: 2024-07-11

Locations

35 sites across 10 countries: United States, Belgium, France, Germany, Greece, Italy, Netherlands, South Korea, Spain, United Kingdom