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A Phase Ib Open-label, Multi-center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced and Selected Solid Tumors

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Trial Information

A Phase Ib Open-label, Multi-center, Dose Escalation and Expansion Study of Orally Administered MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors


Inclusion Criteria:



- Histologically/cytologically confirmed, advanced solid tumors

- Measurable disease as determined by RECIST 1.1

Exclusion Criteria:

- Primary CNS tumor or CNS tumor involvement

- Diabetes mellitus

- Unacceptable ocular/retinal conditions

- Clinically significant cardiac disease or impaired cardiac function

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Dose Limiting Toxicities (DLT)

Outcome Description:

Toxicity will be assessed using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 unless otherwise specified. A DLT is defined as an adverse event or abnormal laboratory value assessed as at least possibly related to the study medication, occurs ≤ 28 days following the first dose of BYL719 and MEK162 (Cycle 1), and meets any of the protocol-specified DLT criteria.

Outcome Time Frame:

during the first cycle (28 days) of treatment with BYL719 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:

CMEK162X2109

NCT ID:

NCT01449058

Start Date:

April 2011

Completion Date:

March 2014

Related Keywords:

  • Advanced and Selected Solid Tumors
  • Advanced solid tumor,
  • dose escalation,
  • RAS/BRAF mutation,
  • PI3K inhibitor,
  • MEK inhibitor,
  • BYL719,
  • MEK162
  • Neoplasms

Name

Location

Massachusetts General Hospital CCPOBoston, Massachusetts  02114
University of Utah / Huntsman Cancer Institute Huntsman (3)Salt Lake City, Utah  84103