Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01275222
Status:
COMPLETED
Last Update Posted:
2021-06-25
First Post:
2011-01-10
Brief Title:
Everolimus in Combination With Imatinib in Patients With Glivec RefractoryResistant Gastrointestinal Stromal Tumors
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase I-II Open-label Study of RAD001 in Combination With GlivecGleevec Imatinib in Patients With GlivecGleevec-refractoryResistant Gastrointestinal Stromal Tumors
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial was a Phase III non-randomized open label multi-center study following a sequential 2-part design
Detailed Description:
The first part Phase I was designed to assess whether there is a pharmacokinetic interaction between GlivecGleevec imatinib and RAD001everolimus 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 mgd Stratum 1 first-line resistantrefractory
Patients resistant to imatinib as well as to post-imatinib drug therapy Stratum 2 post second-line therapy
It was decided to discontinue the study and close to further enrollment based on alternative treatment options that became available Phase 1 and Phase 2 Stratum 1 were ended early on 02-Nov-2006 Investigators were allowed to complete the enrollment in the Phase 2 Stratum 2
Patients resistant to imatinib as first-line drug therapy and in whom the maximum tolerated dose was at least 600 mgd Stratum 1 first-line resistantrefractory
Patients resistant to imatinib as well as to post-imatinib drug therapy Stratum 2 post second-line therapy
It was decided to discontinue the study and close to further enrollment based on alternative treatment options that became available Phase 1 and Phase 2 Stratum 1 were ended early on 02-Nov-2006 Investigators were allowed to complete the enrollment in the Phase 2 Stratum 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None