Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02383927|
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : May 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) HRAS Mutant Tumor Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor||Drug: Tipifarnib||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||November 30, 2020|
|Actual Study Completion Date :||November 30, 2020|
Experimental: Cohort 1
Other Name: Zarnestra
Experimental: Cohort 2
Squamous Head and Neck Cancer
Other Name: Zarnestra
- Objective Response Rate (ORR) [ Time Frame: 24 months (approx. 12 months accrual + 12 months follow up) ]
- Progression-free Survival (PFS) [ Time Frame: 24 months (approx. 12 months accrual + 12 months follow up) ]
- Duration of Response (DOR) [ Time Frame: 24 months (approx. 12 months accrual + 12 months follow up) ]
- Number of Subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Until 30 days after the end of study ]Number of patients that experience Adverse Events (AEs). Adverse Events (AEs) and Serious Adverse Events (SAEs) will be graded according to the NCI-CTCAE (Version 4.03).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383927