Solid Tumors Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Doi T, Tamura K, Tanabe Y, Yonemori K, Yoshino T, Fuse N, Kodaira M, Bando H, Noguchi K, Shimamoto T, Ohtsu A. Phase 1 pharmacokinetic study of the oral pan-AKT inhibitor MK-2206 in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Aug;76(2):409-16. doi: 10.1007/s00280-015-2810-z. Epub 2015 Jun 24. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs) | Day 1 - Day 28 (Cycle 1) | Yes | |
Secondary | Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax | Day 1 - Day 28 (Cycle 1) | No |
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