TRIAL DETAIL
A Study to Evaluate the Safety and Pharmacokinetics of KTN0158 in Adult Patients With Advanced Solid Tumors
Drug: |
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Trial Name: |
A Study to Evaluate the Safety and Pharmacokinetics of KTN0158 in Adult Patients With Advanced Solid Tumors |
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NCT#: |
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Conditions: |
Any type of Cancer |
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Status: |
Ongoing, but not recruiting |
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Phase: |
1 |
Start Date 12/01/2015 |
Age of Trial (yrs) 9 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
KIT/PDGFRA inhibitor |
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Strategy: |
Block KIT + Stimulate the immune system |
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Trial Type: |
Specifically GIST plus other cancers |
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Other Protocol IDs: |
KTN0158-CL-001 |
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Sponsor: |
Koltan Pharmaceuticas |
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Patient Contact: |
Lisa Kamen, MHA
203-907-0958
lisa.kamen@kolltan.com |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Intravenous |
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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. |
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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 |
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3181 S.W. Sam Jackson Park Rd. |
Portland |
OR |
97239 |
USA |
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55 Fruit Street |
Boston |
MA |
02114 |
USA |