Drug: |
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Trial Name: |
Everolimus in Combination With Imatinib in Patients With Glivec Refractory/Resistant Gastrointestinal Stromal Tumors |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Completed |
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Phase: |
2 |
Start Date 11/01/2002 |
Age of Trial (yrs) 21.9 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
KIT/PDGFRA inhibitor
mTOR inhibitor |
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Strategy: |
Block KIT
Block KIT Signal Path |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
CRAD001C2206 |
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Sponsor: |
Novartis Pharmaceuticals |
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Patient Contact: |
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Oral |
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Trial Notes: |
This trial was a Phase I/II, non-randomized, open label, multi-center study, following a sequential 2- part design. The first part, Phase I, was designed to assess whether there is a pharmacokinetic interaction between Glivec/Gleevec (imatinib) and RAD001(everolimus) as well as to collect safety data when these two drugs are co-administered. The second part, (Phase II), was designed to assess the potential efficacy of the combination in imatinib-resistant GIST patients in two strata of patients: * Patients resistant to imatinib as first-line drug therapy and in whom the maximum tolerated dose was at least 600 mg/d (Stratum 1, first-line resistant/refractory) * Patients resistant to imatinib as well as to post-imatinib drug therapy (Stratum 2, post second-line therapy) |
Trial Links |
Trial Results |
Name |
Address |
City |
State |
Zip |
Country |
450 Brookline Ave |
Boston |
MA |
02215-5450 |
USA |
|
333 Cottman Ave |
Philadelphia |
PA |
19111 |
USA |
|
10945 Le Conte Ave. |
Los Angeles |
CA |
90095 |
USA |
|
3181 S.W. Sam Jackson Park Rd. |
Portland |
OR |
97239 |
USA |
|
28 rue Laennec |
Lyon |
Rhone |
69373 |
France |
|
Schwanebecker Chaussee |
Berlin |
Germany |