Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
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|ClinicalTrials.gov Identifier: NCT02383927|
Recruitment Status : Recruiting
First Posted : March 10, 2015
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer Squamous Head and Neck Cancer 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. Subject 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 RAS gene status at a central facility.
Subjects will be enrolled into two nonrandomized cohorts:
- Cohort 1: Malignant thyroid tumors with HRAS mutations.
- Cohort 2: Squamous Head and Neck Cancer with HRAS mutations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 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|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||August 2018|
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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383927
|Contact: Kamn Lacroixfirstname.lastname@example.org|
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