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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
Open (Enrolling)
Both
Advanced and Selected Solid Tumors

Thank you

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/OncologyLos Angeles, California  90095