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OpenTrials
Completed

NCT Number: NCT01469130

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

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigative Site, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEK162

Drug

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

Primary outcomes

  1. Incidence of Dose limiting toxicities

    Time frame: 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 outcomes

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

    Time frame: 4 months

    Incidence and severity of adverse events and serious adverse events, changes in laboratory values will be measured during the treatment.

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

    Time frame: 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.

  3. Tumor responses according to RECIST 1.1

    Time frame: 4 months

    Tumor responses will be measured according to RECIST 1.1

  4. Levels of p-ERK in tumor and skin

    Time frame: 4 months

    Levels of p-ERK in tumor during treatment and skin for first 2 weeks will be measured.

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2018
First posted
Nov 10, 2011
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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