- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01071018
A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)
September 4, 2015 updated by: Merck Sharp & Dohme LLC
A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QOD Schedule
QOD Schedule, 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 Names:
|
Experimental: QW Schedule
QW Schedule, 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)
Time Frame: Day 1 - Day 28 (Cycle 1)
|
Day 1 - Day 28 (Cycle 1)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax
Time Frame: Day 1 - Day 28 (Cycle 1)
|
Day 1 - Day 28 (Cycle 1)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 17, 2010
First Submitted That Met QC Criteria
February 17, 2010
First Posted (Estimate)
February 18, 2010
Study Record Updates
Last Update Posted (Estimate)
September 7, 2015
Last Update Submitted That Met QC Criteria
September 4, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2206-007
- 2010_509
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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