West Cancer Center

MOLECULARLY TARGETED; Metastatic; >/=2nd line; P2P: "SIGNATURE CMEK162AUS11"

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 3- MEK162 for patients with RAS/RAF/MEK activated tumors

Title

Novartis CMEK162AUS11

Study Title

Modular phase II study to link targeted therapy to patients with pathway activated tumors: Module 3- MEK162 for patients with RAS/RAF/MEK activated tumors

Site Link

NCT01885195

Malignancy

y- Advanced Cancer; Bladder, Esophagus, AML (acute myeloid leukemia), small intestine, papillary thyroid

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

>/=2nd line

Investigational Agent

MEK162

Drug Class

MEK 1/2 inhibitor

Lee Schwartzberg, MD

Sponsor

Novartis Pharmaceuticals

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT01885195

Key Eligibility Criteria Details

None of the following malignancies:
NSCLC (non-small cell lung cancer)
CRC (colorectal cancer)
Melanoma
Pancreatic
Biliary
Low-grade serous ovarian
Mutation in any of the following:
RAF, RAS, NF1, MEK

Objective

Primary- CBR: Secondary- ORR, PFS, OS, DoR, Safety

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Any of following:RAS mutation RAF mutation NF1 mutation MEK mutation

Dosing Frequency

MEK162 45mg orally bid

Control Agents

N/A

Study Protocol

Randomized