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

NCT01071018 | Completed Phase 1

• 2 other identifiers: 2206-0072010_509
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumors

Keywords

locally advanced or metastatic solid tumors

Outcome Measures

Primary Outcomes (1)

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

  Day 1 - Day 28 (Cycle 1)

Secondary Outcomes (1)

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

  Day 1 - Day 28 (Cycle 1)

Study Arms (2)

QOD Schedule

EXPERIMENTAL

QOD Schedule, MK2206 every other day

Drug: MK2206 every other day

QW Schedule

EXPERIMENTAL

QW Schedule, MK2206 once weekly

Drug: MK2206 once weekly

Interventions

MK2206 every other day DRUG

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

QOD Schedule

MK2206 once weekly DRUG

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

QW Schedule

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 26104654 BACKGROUND

MeSH Terms

Interventions

MK 2206

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 7, 2015

Record last verified: 2015-09