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.
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced and Selected Solid Tumors
Both
Advanced and Selected Solid Tumors
Trial Information
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.
Inclusion Criteria:
- histologically/ cytologically confirmed, advanced non resectable solid tumors
- Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0
Exclusion Criteria:
- Patients with primary Central Nervous System (CNS) tumor or CNS tumor involvement.
- Clinically manifested diabetes mellitus - Unacceptable ocular/retinal conditions
Other protocol-defined inclusion/exclusion criteria may apply.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum Tolerated Dose (MTD) and/or recommended phase II dose (RP2D) and schedule of BKM120+GSK1120212
Outcome Time Frame:
in average 1 year
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CBKM120B2101
NCT ID:
NCT01155453
Start Date:
April 2010
Completion Date:
July 2013
Related Keywords:
- Advanced and Selected Solid Tumors
- BKM120
- RAS RAF mutations,
- triple negative breast cancer,
- pancreatic cancer,
- PI3K inhibitor,
- MEK inhibitor
- Neoplasms
Name | Location |
|---|---|
| MD Anderson Cancer Center/University of Texas Dept of MD Anderson (8) | Houston, Texas 77030-4009 |
| University of California at Los Angeles Div. of Hematology/Oncology | Los Angeles, California 90095 |
