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Trial record 14 of 50 for:    MK-2206

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01071018
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : September 7, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 17, 2010
First Posted Date  ICMJE February 18, 2010
Last Update Posted Date September 7, 2015
Study Start Date  ICMJE February 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs) [ Time Frame: Day 1 - Day 28 (Cycle 1) ]
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
 (submitted: February 17, 2010)
Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax [ Time Frame: Day 1 - Day 28 (Cycle 1) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE
  • 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 * 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.

*   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
Actual Enrollment  ICMJE
 (submitted: April 18, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2010)
30
Actual Study Completion Date  ICMJE September 2011
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Japan
 
Administrative Information
NCT Number  ICMJE NCT01071018
Other Study ID Numbers  ICMJE 2206-007
2010_509
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date September 2015

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