Phase 2 Completed N=63 Treatment

Phase II Study of Tipifarnib in Squamous Head and Neck Cancer With HRAS Mutations

Thyroid Cancer · Head and Neck Cancer · HRAS Mutant Tumor · Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor

Source: ClinicalTrials.gov NCT02383927 ↗

Enrolled (actual)

Serious AEs

63.5%

Results posted

Jul 2024

Primary outcomePrimary: Antitumor Activity by Objective Response Rate (ORR) — 0.0; 0.0; 43.5; 28.6 percentage of participants

Summary

Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available.

Outcome Measures

Outcome	Result	p-value
PRIMARY Antitumor Activity by Objective Response Rate (ORR)	0.0; 0.0; 43.5; 28.6	—
SECONDARY Number of Subjects That Experienced One or More Treatment-emergent Adverse Events (TEAEs)	13; 10; 30; 10; 6; 5	—

Eligibility Criteria

Inclusion Criteria

histologically or cytologically confirmed diagnosis of thyroid cancer (cohort 1) 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 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

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Data sourced from ClinicalTrials.gov (NCT02383927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.