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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01071018
First received: February 17, 2010
Last updated: April 18, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: MK2206 every other day
Drug: MK2206 once weekly
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs) [ Time Frame: Day 1 - Day 28 (Cycle 1) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax [ Time Frame: Day 1 - Day 28 (Cycle 1) ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QOD Schedule
QOD Schedule, MK2206 every other day
Drug: MK2206 every other day
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 Name: MK2206
Experimental: QW Schedule
QW Schedule, MK2206 once weekly
Drug: MK2206 once weekly
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 Name: MK2206

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071018

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01071018     History of Changes
Other Study ID Numbers: MK-2206-007, 2010_509
Study First Received: February 17, 2010
Last Updated: April 18, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck Sharp & Dohme Corp.:
locally advanced or metastatic solid tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014