Know Cancer

forgot password

A Phase Ib Open-label Dose Escalation Study of MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

Thank you

Trial Information

A Phase Ib Open-label Dose Escalation Study of MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E Mutations

Inclusion Criteria:

Patients with histologically or cytologically confirmed and non-resectable advanced solid
tumors for which no further effective standard therapy exists.

- The patients' tumors must contain documented activating somatic BRAFV600E* , NRAS or
KRAS mutations (except for pancreatic cancer)

- All patients enrolled MUST provide fresh or archival tumor samples at baseline to
enable central confirmation of BRAF or KRAS/NRAS mutations

- Measurable, or non-measurable but evaluable disease as determined by RECIST

- Adequate bone marrow function

- Adequate hepatic and renal function

- Adequate cardiovascular function

- Negative serum β HCG test (female patients of childbearing potential only) within 72
hrs prior to first dose

Exclusion Criteria:

- Patients with a history of primary central nervous system tumors or brain metastases
or who have signs/symptoms attributable to brain metastases and have not been
assessed with radiologic imaging to rule out the presence of brain metastases

- Current evidence of retinal disease; or ophthalmopathy as assessed by ophthalmologic
examination at baseline that would be considered a risk factor for CSR/RVO (e.g.,
optic disc cupping, visual field defects, IOP > 21 mm Hg)

- Impaired cardio-/vascular function or clinically significant cardiovascular diseases,
including any of the following:

- History/evidence of acute coronary syndromes (including MI, unstable angina,
CABG, coronary angioplasty, or stenting) ≤ 6 months prior to starting study

- Thromboembolic event (DVT, CVA, PE) ≤ 6 months prior to starting study

- Symptomatic CHF, history or current evidence of clinically significant cardiac
arrhythmia and/or conduction abnormality

- Uncontrolled arterial hypertension, defined as BP > 140/100 mmHg (average of 3
consecutive readings)

- History of melena, hematemesis or hemoptysis within the last 3 months

- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test (> 5 mIU/mL)

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


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 the first 28 days of treatment with RAF265 and MEK162

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

July 2013

Related Keywords:

  • Advanced Solid Tumors
  • advanced Solid tumors
  • harboring RAS
  • harboring BRAFV600E
  • Neoplasms



H. Lee Moffitt Cancer Center/University of South Florida Moffitt 4 Tampa, Florida  33612
Oregon Health & Science University OHSU 3 Portland, Oregon  97239
University of Utah / Huntsman Cancer Institute Huntman 2 Salt Lake City, Utah  84103