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

Study Overview
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Brief Summary
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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.

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: MK2206 every other day
* Drug: MK2206 once weekly


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QOD Schedule<br>QOD Schedule, MK2206 every other day | Drug: MK2206 every other day<br>* 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.<br>* Other names: MK2206;|
| Experimental: QW Schedule<br>QW Schedule, MK2206 once weekly | Drug: MK2206 once weekly<br>* 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.<br>* Other names: MK2206;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs) |  | Day 1 - Day 28 (Cycle 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax |  | Day 1 - Day 28 (Cycle 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locally advanced or metastatic solid tumors