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A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors Harboring a BRAF V600 Mutation

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Trial Information

A Phase Ib/II, Multicenter, Open-label, Dose Escalation Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF V600 - Dependent Advanced Solid Tumors


Inclusion Criteria:



Histologically confirmed diagnosis of locally advanced or metastatic melanoma (stage IIIB
to IV per American Joint Committee on Cancer [AJCC]), or confirmed diagnosis of
non-resectable advanced metastatic colorectal cancer (mCRC), or any other indication upon
agreement with the Sponsor, whose disease has progressed despite previous antineoplastic
therapy or for whom no further effective standard therapy is available

- Written documentation of BRAF V600E mutation, or any other BRAF V600 mutation

- Evidence of measurable disease as determined by RECIST v1.1

- World Health Organization (WHO) Performance Status ≤ 2

- Negative serum pregnancy test within 72 hours prior to the first study dose in all
women of childbearing potential

Exclusion Criteria:

Progressive disease following prior treatment with RAF-inhibitors in combination with
MEK-inhibitors

- Symptomatic or untreated leptomeningeal disease

- Symptomatic brain metastases. Patients are not permitted to receive enzyme inducing
anti-epileptic drugs

- Known acute or chronic pancreatitis

- History or current evidence of retinal disease, retinal vein occlusion or
ophthalmopathy

- Clinically significant cardiac disease

- Patients with abnormal laboratory values at Screening/baseline

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral LGX818/MEK162

- Previous or concurrent malignancy

- Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Phase Ib: Estimation of Maximum Tolerated Dose (MTD) by measuring incidence of dose limiting toxicities (DLT)

Outcome Description:

To estimate the MTD(s) and/or rapid phase 2 dose(s) (RP2D(s)) of oral LGX818 in combination with oral MEK162 in patients with BRAF V600-dependent advanced solid tumors by measuring the incidence of DLTs as defined by the protocol.

Outcome Time Frame:

up to 8 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CMEK162X2110

NCT ID:

NCT01543698

Start Date:

May 2012

Completion Date:

September 2015

Related Keywords:

  • Solid Tumors Harboring a BRAF V600 Mutation
  • Advanced solid tumor,
  • BRAF V600 mutation
  • Neoplasms

Name

Location

Massachusetts General Hospital Mass General 2Boston, Massachusetts  02114
MD Anderson Cancer Center/University of Texas MD Univ TXHouston, Texas  77030-4009
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns HopkinsBaltimore, Maryland  21231
H. Lee Moffitt Cancer Center & Research Institute Moffitt SC 2Tampa, Florida  33612