A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BKM120 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Solid Tumors,, Selected Solid Tumors
Both
Advanced Solid Tumors,, Selected Solid Tumors
Trial Information
A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BKM120 Plus MEK162 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
Exclusion Criteria:
- Patients with primary CNS tumor or CNS tumor involvement.
- 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:
Incidence of Dose Limiting Toxicities
Outcome Time Frame:
during Cycle 1 of treatment with BKM120 and MEK162
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CMEK162X2101
NCT ID:
NCT01363232
Start Date:
August 2011
Completion Date:
February 2014
Related Keywords:
- Advanced Solid Tumors,
- Selected Solid Tumors
- BKM120,
- MEK162,
- RAS RAF mutations,
- triple negative breast cancer
- pancreatic cancer, ovarian cancer,
- NSCLC progressed on EGFR TKI
- PI3K inhibitor,
- MEK inhibitor
- Neoplasms
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center MSKCC (2) | New York, New York 10021 |
| Cancer Centers of the Carolinas CCC Faris | Greenville, South Carolina 29605 |
| Massachusetts General Hospital Mass General 2 | Boston, Massachusetts 02114 |
| MD Anderson Cancer Center/University of Texas MD Anderson PSC | Houston, Texas 77030-4009 |
| Wayne State University/Karmanos Cancer Institute Study Coordinator | Detroit, Michigan 48201 |
