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A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BEZ235 Plus MEK162 in Adult Patients With Selected Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific, Solid Tumor

Thank you

Trial Information

A Phase Ib, Open-label, Multi-center, Dose-escalation and Expansion Study of an Orally Administered Combination of BEZ235 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 1.0

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:

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities

Outcome Description:

A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination

Outcome Time Frame:

during Cycle 1 of treatment with BEZ235 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:

CMEK162X2103

NCT ID:

NCT01337765

Start Date:

July 2011

Completion Date:

August 2013

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Solid Tumor
  • BEZ235,
  • MEK162
  • RAS RAF mutations,
  • triple negative breast cancer
  • pancreatic cancer,
  • NSCLC progressed on EGFR TKI
  • PI3K/mTOR inhibitor,
  • MEK inhibitor
  • Advanced and selected solid tumors
  • Neoplasms

Name

Location

University of Wisconsin Univ WiscMadison, Wisconsin  53792
Massachusetts General Hospital Mass General 2Boston, Massachusetts  02114
MD Anderson Cancer Center/University of Texas MD Anderson PSCHouston, Texas  77030-4009