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Report for Clinical Trial NCT01243346

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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 D842-related Mutant GIST
MeSH:Gastrointestinal Stromal Tumors
HPO:Gastrointestinal stroma tumor

1 Interventions

Name: Crenolanib besylate (CP-868,596-26), Dose: 140mg BID

Description: Highly potent inhibitor of both PDGFR receptors alpha and beta
Type: Drug
Group Labels: 1

Crenolanib (CP-868,596)


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

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 3 SNPs

SNPs


1 D842V

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. --- D842V ---

To determine the response rate of patients with advanced D842V mutant GIST, when treated with Crenolanib (CP-868,596). --- D842V ---

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).. Obtain toxicity information. --- D842V ---

To obtain additional toxicity information in patients with advanced GIST with the D842V mutation in the PDGFRA gene.. PKPD analysis. --- D842V ---

To obtain additional PK, pharmacodynamic and plasma inhibitory assay information in patients with advanced GIST with the D842V mutation in the PDGFRA gene.. Inclusion Criteria - Male or female, of any racial or ethnic group - Age 18 years or older - Life expectancy of greater than 12 weeks - Patient able and willing to provide informed consent - Normal liver function, defined as AST and ALT ≤2.5x ULN, and Total Bilirubin ≤ 2x ULN. - Total creatinine ≤ 1.5x ULN - ECOG Performance Status 0 - 2 (Appendix II) - Patients must have histologically or cytologically confirmed GIST with a D842-related mutation or deletion on the PDGFRA gene - Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. --- D842V ---

In preclinical models of cell lines with the D842V mutation in the PDGFRA gene, crenolanib (CP-868,596) blocked phosphorylation of PDGFRα at nanomolar concentrations, suggesting that it may provide a clinical benefit to patients with D842V mutant GIST. --- D842V ---

In preclinical models of cell lines with the D842V mutation in the PDGFRA gene, crenolanib (CP-868,596) blocked phosphorylation of PDGFRα at nanomolar concentrations, suggesting that it may provide a clinical benefit to patients with D842V mutant GIST. --- D842V --- --- D842V ---

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 --- --- D842V ---

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 --- --- D842V --- --- T674I --- --- D842V ---


2 T674I

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 --- --- D842V --- --- T674I ---


3 V561D

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 ---



HPO Nodes


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