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CompletedNCT01071018Updated Sep 7, 2015

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

A Phase 1 interventional study of MK2206 every other day and MK2206 once weekly in Solid Tumors, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-09-07.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Tumors

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Keywords

  • locally advanced or metastatic solid tumors
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    QOD Schedule

    QOD Schedule, MK2206 every other day

    Drug: MK2206 every other day

  • Experimental
    QW Schedule

    QW Schedule, MK2206 once weekly

    Drug: MK2206 once weekly

Interventions

  • DrugMK2206 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.

    Also known as: MK2206

  • DrugMK2206 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.

    Also known as: MK2206

06

What researchers measure

Primary outcomes

  1. Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)

    Time frame: Day 1 - Day 28 (Cycle 1)

Secondary outcomes

  1. Assess pharmacokinetic (PK) profile of MK2206 by determining parameters: AUC, Cmax, and Tmax

    Time frame: Day 1 - Day 28 (Cycle 1)

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 26104654 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01071018
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Feb 18, 2010
Start date
Feb 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Sep 7, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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