Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01155453
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2010-06-17
Brief Title:
A Study to Investigate Safety Pharmacokinetics PK and Pharmacodynamics PD of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase Ib Open-label Multi-center Dose-escalation Study of Oral BKM120 in Combination With Oral GSK1120212 in Adult Patients With Selected Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-06
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 is an open label dose finding phase Ib clinical trial to determine the maximum tolerated dose MTD and or recommended phase II dose RP2D and schedule for the PI3K Phosphatidylinositol 3-Kinase inhibitor BKM120 given in combination with the MEK inhibitor GSK1120212 in patients with selected advanced solid tumors The focus will be on tumors with RASRAF mutations and on triple negative breast cancer
Both study drugs will be administered once daily orally on a continuous schedule a treatment cycle is defined as 28 days
Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable dose-limiting toxicity DLT in more than 33 of the treated patients At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combinations safety and pharmacokinetics or pharmacodynamics
Upon declaration of MTD andor RP2D patients will be enrolled to an expansion part of the study to further assess safety as well as to learn more about the efficacy of the study drug combination
Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC
Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer
Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer
Both study drugs will be administered once daily orally on a continuous schedule a treatment cycle is defined as 28 days
Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable dose-limiting toxicity DLT in more than 33 of the treated patients At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combinations safety and pharmacokinetics or pharmacodynamics
Upon declaration of MTD andor RP2D patients will be enrolled to an expansion part of the study to further assess safety as well as to learn more about the efficacy of the study drug combination
Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC
Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer
Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-017157-35 | EUDRACT_NUMBER | None | None |