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

NCT01469130 | Completed Phase 1

• 1 other identifier: CMEK162X1101
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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

Keywords

MEK, Advanced solid tumor

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose limiting toxicities

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

  4 weeks

Secondary Outcomes (4)

• Incidence and severity of adverse events and serious adverse events, changes in laboratory values

  4 months

• Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.

  2 months

• Tumor responses according to RECIST 1.1

  4 months

• Levels of p-ERK in tumor and skin

  4 months

Study Arms (1)

MEK162

EXPERIMENTAL

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.

Drug: MEK162

Interventions

MEK162 DRUG

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

MEK162

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Array Biopharma, now a wholly owned subsidiary of Pfizer: lead

Study Sites (2)

Pfizer Investigative Site

Nagoya, Aichi-ken, 466-8560, Japan

Location

Pfizer Investigative Site

Yufu, Oita Prefecture, 879-5593, Japan

Location

MeSH Terms

Interventions

binimetinib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: February 1, 2018
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

JP (2)