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

NCT ID: NCT01469130

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2018-02-01

Brief Summary

In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MEK162

MEK162 will be administered orally once on Day 1 of Cycle 1 and continuously on a BID schedule, starting on Day 2 of Cycle 1 and on Day 1 of subsequent cycles. Each cycle will be 28 days in duration. Dose will be escalated and starting dose is 30 mg. Any doses that are missed should be skipped and should not be replaced or made up during the evening dosing or on a subsequent day, whichever applies.

The prescribed BID doses should be taken 12 ± 2 hrs apart.

Group Type: EXPERIMENTAL

MEK162

Intervention Type: DRUG

MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).

Interventions

MEK162

MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).

Intervention Type: DRUG

Eligibility Criteria

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 sample.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigative Site

Nagoya, Aichi-ken, Japan

Pfizer Investigative Site

Yufu, Oita Prefecture, Japan

Countries

Japan

Other Identifiers

CMEK162X1101

Identifier Type: -

Identifier Source: org_study_id