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Tipifarnib

Phase 2

HRAS Gene Mutation | Small molecule | Other |Kura Oncology, Inc.|Last Updated: Jun 21, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
NO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment296
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03719690Safety and Efficacy of Tipifarnib in Head and Neck Cancer With HRAS Mutations and Impact of HRAS on Response to TherapyPHASE2 COMPLETED 296 — — Mar 15, 2019May 2, 2023Jun 21, 2024102 United States, Australia +14
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Study Endpoints
Primary Endpoints
Objective Response Rate (ORR) in High Variable Allele Frequency (VAF) Population, as Assessed by Independent Review Facility (IRF)
Up to approximately 28 months

ORR was defined as the percentage of participants who experienced a best overall response (BOR) of complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRF. 95% confidence interval (CI) was calculated by the exact binomial (Clopper-Pearson) method.

Secondary Endpoints
ORR in All VAF Population, as Assessed by IRF
Up to approximately 28 months
Duration of Response (DoR) in High VAF Population, as Assessed by IRF
Up to approximately 28 months
DoR in All VAF Population, as Assessed by IRF
Up to approximately 28 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AIM-HNEXPERIMENTALTipifarnib, Oral Tablet. Dose Level 1 orally, bid on days 1-7 and 15-21 of 28-day treatment cycles
SEQ-HNNO_INTERVENTIONHNSCC patients in whom HRAS mutations were not identified (wild type HRAS HNSCC) and who consent to provide first line outcome data and additional follow up.
Interventions
NameTypeDescription
TipifarnibDRUGTablet for oral administration
HRAS Detection AssayDEVICEIn Vitro Assay to detect HRAS mutations
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites102

Inclusion Criteria: AIM-HN 1. At least 18 years of age. 2. Histologically confirmed head and neck cancer (oral cavity, pharynx, larynx, sinonasal, nasopharyngeal, or unknown primary) of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or with...

Countries:United StatesAustraliaAustriaBelgiumDenmarkGermanyGreeceItalyMalaysiaNetherlandsNorwaySouth KoreaSpainTaiwanThailandUnited Kingdom
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Competitive Landscape -Genetic Mutations 6 trials
CompanyTickerTrialsLead PhaseDrugs
Tango Therapeutics, Inc.TNGX1PHASE1TNG462, RMC-9805, RMC-6236, mFOLFIRINOX, gemcitabine/nab-paclitaxel
Myriad Genetics, Inc.MYGN1PHASE1Melphalan, BCNU, Vitamin B12B, Vitamin C
Adlai Nortye Ltd. Sponsored ADRANL1PHASE1AN9025
Pasithea Therapeutics Corp.KTTA1PHASE1PAS-004
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