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

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT01071018

First received: February 17, 2010

Last updated: April 18, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 17, 2010

Last Updated Date

April 18, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01071018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Solid Tumors

Intervention ^ICMJE

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
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

Study Arm (s)

Experimental: QOD Schedule
QOD Schedule, MK2206 every other day

Intervention: Drug: MK2206 every other day
Experimental: QW Schedule
QW Schedule, MK2206 once weekly

Intervention: Drug: MK2206 once weekly

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

September 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01071018

Other Study ID Numbers ^ICMJE

MK-2206-007, 2010_509

Has Data Monitoring Committee

Responsible Party

Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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