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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469130
• Other study ID #: CMEK162X1101
• Status: Completed
• Phase: Phase 1
• Start date: November 2011
• Est. completion date: February 1, 2018

Study information

• Verified date: September 2020
• Source: Array BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 1, 2018
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Pfizer Investigative Site	Nagoya-city	Aichi
Japan	Pfizer Investigative Site	Yufu	Oita

Sponsors (1)

Lead Sponsor	Collaborator
Array Biopharma, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence and severity of adverse events and serious adverse events, changes in laboratory values	Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.	4 months
Secondary	Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.	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.	2 months
Secondary	Tumor responses according to RECIST 1.1	Tumor responses will be measured according to RECIST 1.1	4 months
Secondary	Levels of p-ERK in tumor and skin	Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured.	4 months