Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations
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|ClinicalTrials.gov Identifier: NCT02383927|
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : May 14, 2021
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|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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- histologically or cytologically confirmed diagnosis of thyroid cancer (cohort 1: Note: Cohort closed to further enrolment) or Squamous Cell Carcinoma head and neck cancer (cohort 2) or Squamous Cell Carcinoma other than HNSCC (cohort 3) for which there is no curative therapy available.
- tumor that carries a missense HRAS mutation ith a variant allele frequency (VAF) > 20%.
- Subject consents to provide at least 10 unstained tumor slides for retrospective testing of HRAS gene tumor status
- Subject has measurable disease according to RECIST v1.1 and has relapsed or is refractory to prior therapy.
- At least 2 weeks since the last systemic therapy or radiotherapy regimen prior to enrolment
- ECOG PS 0 or 1
- Acceptable liver function
- Acceptable renal function
- Acceptable hematologic status • Serum albumin ≥ 3.5 g/dL. Subjects with tumors potentially highly sensitive to tipifarnib (HRAS mutant VAF ≥ 35%) may be enrolled despite a serum albumin < 3.5 g/dL.
- Prior treatment with an FTase inhibitor
- History of relevant coronary heart disease or myocardial infarction within last 3 years, NYHA Grade III or greater congestive heart failure, cerebro-vascular attack within the prior year, or serious cardiac arrhythmia requiring medication except atrial fibrillation.
- Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Controlled brain metastases that require continuous high dose corticosteroid use within 4 weeks of Day 1.
- Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks first dose
- Major surgery, other than diagnostic surgery, within 4 weeks prior to first dose, without complete recovery.
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. Known infection with HIV, or an active infection with hepatitis B or hepatitis C
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
|Responsible Party:||Kura Oncology, Inc.|
|Other Study ID Numbers:||
|First Posted:||March 10, 2015 Key Record Dates|
|Last Update Posted:||May 14, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site