SNPMiner Trials by Shray Alag


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Report for Mutation T81C

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 An Open Label Phase II Study of Tipifarnib in Advanced Squamous Non-small Cell Lung Cancer With HRAS Mutations

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.

NCT03496766 Non Small Cell Lung Cancer Drug: Tipifarnib
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO: Neoplasm of the lung Non-small cell lung carcinoma

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 ---

Primary Outcomes

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 mutations

Measure: 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

Secondary Outcomes

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 study

Measure: 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 treatment

Measure: 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


HPO Nodes


Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8