SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation V561D

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 Phase II Study of Crenolanib (CP-868,596), a Selective and Potent Inhibitor of PDGFR, for the Treatment of Patients With Advanced Gastrointestinal Stromal Tumors With the D842-related Mutations and Deletions, Including the D842V Mutation, in the PDGFRA Gene

This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.

NCT01243346
Conditions
  1. D842-related Mutant GIST
Interventions
  1. Drug: Crenolanib besylate (CP-868,596-26), Dose: 140mg BID
MeSH:Gastrointestinal Stromal Tumors
HPO:Gastrointestinal stroma tumor

In addition, crenolanib was also active in inhibiting phosphorylation of cell lines with two point mutations (double mutants) PDGFRA V561D + D842V and PDGFRA T674I + D842V. --- V561D ---

Primary Outcomes

Description: To determine the response rate of patients with advanced D842V mutant GIST, when treated with Crenolanib (CP-868,596). Response will primarily be determined by RECIST criteria

Measure: The primary end-point is overall response rate

Time: 1.5 years

Secondary Outcomes

Description: To determine the progression free survival rate at 6 months in patients with advanced GIST with the D842V mutation in the PDGFRA gene, when treated with CP-868,596 (crenolanib).

Measure: Progression free survival rate

Time: 6 months

Description: To obtain additional toxicity information in patients with advanced GIST with the D842V mutation in the PDGFRA gene.

Measure: Obtain toxicity information

Time: 1 year

Description: To obtain additional PK, pharmacodynamic and plasma inhibitory assay information in patients with advanced GIST with the D842V mutation in the PDGFRA gene.

Measure: PKPD analysis

Time: 1 year


HPO Nodes