TRIAL DETAIL

A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor

Drug:
Trial Name:
A Study of CS3007 in Subjects With Gastrointestinal Stromal Tumor
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
1/2
Start Date 08/19/2019
Age of Trial (yrs) 1
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor + D842V inhibitor
Strategy:
Block KIT/PDGFRA
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
CS3007-101
Sponsor:
CStone Pharmaceuticals
Patient Contact:
Wendie YUAN +86 21 61097678 cstonera@cstonepharma.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:

For phase I study, the subject must have histologically or cytologically confirmed unresectable or metastatic GIST that progressed after imatinib and at least one additional TKI treatment, or who cannot tolerate the standard treatment or have D842V mutation in the PDGFRα gene.

For phase II study:

i) Group 1: Chinese subjects with unresectable GIST harboring D842V mutation in PDGFRα gene.

ii) Group 2: Chinese subjects with unresectable GIST that has progressed following imatinib treatment or who don't tolerate imatinib (including in the adjuvant setting) and who have not received any other kinase inhibitor treatment. Patients must not have a known D842V mutation in PDGFRα gene.

iii) Group 3: Chinese subjects with unresectable GIST that doesn't harbor D824V mutation in PDGFRα gene and that has progressed despite treatment with imatinib and at least another tyrosine kinase inhibitor.
Subjects with at least one measurable lesion as defined per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
Beijing
China