TRIAL DETAIL

A Study to Evaluate the Safety and Pharmacokinetics of KTN0158 in Adult Patients With Advanced Solid Tumors

Drug:
Trial Name:
A Study to Evaluate the Safety and Pharmacokinetics of KTN0158 in Adult Patients With Advanced Solid Tumors
NCT#:
Conditions:
Any type of Cancer
Status:
Ongoing, but not recruiting
Phase:
1
Start Date 12/01/2015
Age of Trial (yrs) 6.6
Treatment Phase:
Gleevec-resistant
Drug Category:
KIT/PDGFRA inhibitor
Strategy:
Block KIT + Stimulate the immune system
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
KTN0158-CL-001
Sponsor:
Koltan Pharmaceuticas
Patient Contact:
Lisa Kamen, MHA 203-907-0958 lisa.kamen@kolltan.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Intravenous
Trial Notes:
This is a dose-escalation Phase 1 study designed to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose, and the safety profile of KTN0158 in patients with KIT-positive advanced solid malignancies refractory to standard therapy or for which no standard therapy exists.

Inclusion criteria: 3. For patients with GIST, patients will have progressed on at least one prior tyrosine kinase inhibitor therapy or be intolerant. If documented to have SDH deficient or PDGFRA-D842V GIST, no prior therapy is required for study entry.

Trial Links

Trial Results

Drug Information

Kolltan Pharmaceuticals Provides Update on Clinical Pipeline, Corporate Developments and Near-Term Milestones 1/8/2016
 

Trial Sites

Name
Address
City
State
Zip
Country
3322 West End Avenue
Nashville
TN
37203
USA
450 Brookline Ave
Boston
MA
02215-5450
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA
55 Fruit Street
Boston
MA
02114
USA