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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071018
• Other study ID #: 2206-007
• Secondary ID: 2010_509
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2010
• Last updated: September 4, 2015
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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. — View Citation

Outcome

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