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

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: MEK162

• Registration Number: NCT01469130
• Lead Sponsor: Array Biopharma, now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-09
• Study First Posted: 2011-11-10
• Primary Completion: 2014-04
• Study Completion: 2018-02-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MEK162	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tumor responses according to RECIST 1.1	4 months	Tumor responses will be measured according to RECIST 1.1
Incidence and severity of adverse events and serious adverse events, changes in laboratory values	4 months	Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.
Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.	2 months	Plasma concentration of MEK162 and active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite will be measured with serial plasma samples during treatment for first 2 months.
Levels of p-ERK in tumor and skin	4 months	Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured.

Trial Locations

Locations (1)

Pfizer Investigative Site; 🇯🇵 Yufu, Oita, Japan