SNPMiner Trials (Home Page)
Report for Mutation G2032R
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer: a Phase II Trial (PFROST)
This is a phase II study assessing response rate to PF-06463922 in patients with ROS1 translocation resistant to previous crizotinib therapy. Eligible patients will be treated with the study drug until disease progression, unacceptable toxicity or patient refusal. Disease assessment will be performed every 8 weeks according to RECIST criteria.
NCT03439215 Carcinoma, Non-Small-Cell Lung Drug: Lorlatinib MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma
These results, together with its exquisite ROS1 potency and ability to suppress the resistant ROS1 mutations, supports the clinical evaluation of PF-06463922 in ROS1-positive NSCLC, including patients who have developed resistance to crizotinib because of the acquired G2032R mutation and/or brain metastases. --- G2032R ---
Primary Outcomes
Description: Response rate to PF-06463922 in patients with ROS1 translocation resistant to crizotinib
Measure: Response rate to PF-06463922 in patients with ROS1 translocation resistant to crizotinib Time: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 monthsSecondary Outcomes
Description: Progression-free survival (PFS) will be calculated from the time between the baseline/start of treatment visit to the time of first occurrence of progressive disease (PD) or death from any cause. Patients who have neither progressed nor died at time of analysis will be censored at the date of last tumor assessment where non progression was documented (i.e. CR, PR or SD)
Measure: Progression-free survival (PFS), The length of time during and after the treatment of a disease,that a patient lives with the disease but it doesn't get worse. Time: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 monthsDescription: Overall survival (OS) will be calculated from the time between the baseline/start of treatment visit to the date of death, irrespective of the cause of death. Patients still alive at the time of analysis will be censored at the date they were last known to be alive
Measure: Overall Survival (OS): Time from the start of treatment until death from any cause Time: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 monthsDescription: Patients will be closely monitored for signs and symptoms of potential adverse events, and will undergo frequent laboratory tests to assess lipids, pancreas, liver, kidney, and haematological function.
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 monthsDescription: Correlation with additional tumor biomarkers in tumor tissue or blood
Measure: Correlation with additional tumor biomarkers in tumor tissue or blood Time: From date of the first enrolment until the date of last documented progression or date of death from any cause, assessed up to 36 months