There is one clinical trial.
This Phase II study consists of 2 parts: 1) pre-screening phase and 2) treatment phase. The pre-screening phase will investigate the presence of HRAS mutations in subjects with a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (SQ-NSCLC). Subjects may participate in the pre-screening phase at initial diagnosis or following prior lines of therapy for SQ-NSCLC. The treatment phase will investigate the antitumor activity in terms of ORR of tipifarnib in subjects with locally advanced squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutations and for whom there is no curative therapy available.
Non Small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung Subject enrolment may proceed with information available on tumor HRAS status previously generated during the pre-screening phase, but all subjects must consent to provide tumor slides (or tumor tissue block) from a prior diagnostic biopsy for a retrospective testing of RAS gene status, including T81C polymorphism, and other potential biomarkers at a central facility. --- T81C ---
Description: To determine the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with locally advanced unresectable or metastatic, relapsed and/or refractory, squamous non-small cell lung cancer (SQ-NSCLC) with HRAS mutationsMeasure: Overall Response Rate Time: From the first dose until progression disease, assessed from the first dose until the first assessment at week 6 from the first dose
Description: As there is a screening phase where HRAS mutations will be analyzed, the second outcome is to determine the frequency (%) of this mutation in the target population of this studyMeasure: Frequency of HRAS mutations Time: at the beginning of the study, day -7 to day 0
Description: Adverse events will be collected in all the patients in order to now the tolerability of the treatmentMeasure: Tolerability as Incidence of Treatment-Emergent Adverse Events of Tipifarnib Time: from the first dose of treatment until 30 days after the last dose of treatment