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

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Merck:

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

Investigators

Study Director:

Medical Monitor

Merck

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:

locally advanced or metastatic solid tumors

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013