A Combination Study of Tipifarnib and Alpelisib
For patients with HRAS-dependent and/or PIK3CA‑dependent HNSCC now enrolling
For patients with HRAS-dependent and/or PIK3CA‑dependent HNSCC now enrolling
Learn about the tipifarnib monotherapy trial for patients with HRAS-mutant HNSCC.
KURRENT is a Phase 1/2 open-label, combination, dose escalation study of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor, to determine the safety and recommended dose and regimen for the treatment of adult patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified. The codependency of HRAS and PI3K pathways in driving tumor growth provides the rationale for a combination trial of tipifarnib and alpelisib in this subset of HNSCC patients.1
Tipifarnib is an oral investigational monotherapy drug candidate for HRAS-mutant HNSCC. In preclinical models, tipifarnib blocks the activity of an enzyme called farnesyltransferase (FT). It is the only farnesyltransferase inhibitor (FTI) under investigation for HRAS-dependent HNSCC.
Alpelisib is an oral inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. It received FDA approval as PIQRAY®, a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen. Important Safety Information can be found here.4
KURRENT is an open-label, combination, dose escalation study evaluating the safety of the combination of tipifarnib and alpelisib and determining the recommended dosing regimen in recurrent/metastatic HNSCC for adult patients who meet criteria for at least 1 of 2 biomarker-defined cohorts:
Trial Number: KO-TIP-013
ClinicalTrials.gov Identifier: NCT04997902
For full details of inclusion criteria, exclusion criteria, and outcome measures, please visit clinicaltrials.gov.
For full details of inclusion criteria, exclusion criteria, and outcome measures, please visit clinicaltrials.gov.
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For more information, please email: KO-TIP-013@kuraoncology.com.
To talk with a medical science liaison (MSL), please email: medicalaffairs@kuraoncology.com.
REFERENCES: 1. Data on file. KURA Oncology Clinical Trial Protocol: KO-TIP-013. March 24, 2021. 2. Gilardi M, Wang Z, Proietto M, et al. Tipifarnib as a precision therapy for HRAS-mutant head and neck squamous cell carcinomas. Mol Cancer Ther. 2020;19(9):1784-1796. 3. Malone E, Siu LL. Precision medicine in head and neck cancer: myth or reality? Clin Med Insights Oncol. 2018;12:1179554918779581. doi:10.1177/1179554918779581 4. PIQRAY. Prescribing information. Novartis Pharmaceuticals Corporation; 2020.
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Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
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Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
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Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
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Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom
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Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom.
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom.
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom.
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom.
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom.
Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom.