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OpenTrials
Completed

NCT Number: NCT01071018

A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)

This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
  • Has adequate organ function
  • Is ECOG Performance Scale 0-1
  • Has a negative urine pregnancy test if patient is female
  • Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis

Exclusion criteria

  • Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
  • Is currently participating or has participated in a study with an investigational compound or device within 28 days
  • Has a primary central nervous system tumor
  • Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
  • Is a known diabetic who is taking insulin or oral antidiabetic therapy
  • Is pregnant or breastfeeding or planning to become pregnant during the study
  • Is positive HIV antibody, HBs antigen or HCV antibody

Treatment and study plan

MK2206 every other day

Drug

Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles.

Other names: MK2206

MK2206 once weekly

Drug

Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles.

Other names: MK2206

Primary outcomes

  1. Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)

    Time frame: Day 1 - Day 28 (Cycle 1)

Secondary outcomes

  1. Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax

    Time frame: Day 1 - Day 28 (Cycle 1)

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2010
Registry last updated
Sep 7, 2015

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.

Published trials that share one or more normalized conditions with this study.