NCT02383927Phase 2Completed

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

Study sponsor: Kura Oncology, Inc. · KURA

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2020-12-14Actual

Enrollment · participants63Actual

Source updated2024-07-11Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

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

Treatments or interventions studied

TipifarnibDrugAlso known as Zarnestra

Primary outcomes · main study measures

Read the study measures

measure: Antitumor Activity by Objective Response Rate (ORR); description: The ORR of tipifarnib was response assessments according to RECIST 1.1. The estimate of the ORR was calculated based on the maximum likelihood estimator (i.e., crude percentage of subjects whose best overall response was complete response \[CR\] or partial response \[PR\]). The estimate of the ORR was accompanied by 2-sided 95% confidence interval (CI). The 95% CI was estimated using the Wilson score test-based method. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits.; timeFrame: Up to approximately 3 years

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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