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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
Open (Enrolling)
Both
Advanced Solid Tumors,, Selected Solid Tumors

Thank you

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 FarisGreenville, South Carolina  29605
Massachusetts General Hospital Mass General 2Boston, Massachusetts  02114
MD Anderson Cancer Center/University of Texas MD Anderson PSCHouston, Texas  77030-4009
Wayne State University/Karmanos Cancer Institute Study CoordinatorDetroit, Michigan  48201