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A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumor

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Trial Information

A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors

Inclusion Criteria:

- Patients with histologically-confirmed, advanced unresectable solid tumors who have
progressed within three months before screening/baseline visit.

- Availability of a representative formalin fixed paraffin embedded tumor tissue

- At least one measurable or non-measurable lesion

- Age ≥ 18 years

- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2

- Good organ (hepatic, kidney, BM) function at screening/baseline visit.

Exclusion Criteria:

- Brain metastasis unless treated and free of signs/symptoms attributable to brain
metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.

- Impaired cardiac function or clinically significant cardiac disease incl. unstable
angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial
Infarction (AMI) ≤ 3 months prior to starting study drug.

- Women who are pregnant or breast feeding or adults of reproductive potential not
employing an effective method of birth control.

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:


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

Outcome Description:

Incidence of frequency of Dose limiting toxicities during first 4 weeks will be measured according to the commen terminology criteria for adverse events (CTCAE).

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

September 2013

Related Keywords:

  • Advanced Solid Tumor
  • MEK, Advanced solid tumor
  • Neoplasms