Dose Escalation Study With MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors (2206-002) - Full Text View

Purpose

Treatment of patients with locally advanced or metastatic solid tumors who have failed standard therapy or no other standard therapy exists.

Condition	Intervention	Phase
Locally Advanced Tumors Metastatic Solid Tumors Cancer Neoplasms	Drug: MK2206	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase I Dose Escalation Study of Oral MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Characterize safety and tolerability of MK2206 by monitoring incidence rate of adverse experiences [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
Define dose-limiting toxicities (DLT) and maximum tolerated dose by monitoring incidence of protocol-defined DLT [ Time Frame: Day 1 - Day 28 (Cycle 1) ] [ Designated as safety issue: Yes ]
Assess pharmacokinetic (PK) profile of MK2206 by determining parameters such as AUC, Cmax, Tmax [ Time Frame: Day 1 - Day 28 (Cycle 1) ] [ Designated as safety issue: Yes ]
To determine the recommended Phase II dose of MK2206 by assessing safety/tolerability, PK and pharmacodynamics of MK2206 [ Time Frame: study duration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate target engagement following treatment with MK2206 by assessing pharmacodynamics in tissue [ Time Frame: Day 1 - Day 28 (Cycle 1) ] [ Designated as safety issue: No ]
Evaluate anti-tumor activity following treatment with MK2206 by assessing tumor response and clinical benefit [ Time Frame: every 56 days, beginning on Day 63 ] [ Designated as safety issue: No ]

Enrollment:	104
Study Start Date:	April 2008
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: QOD Schedule MK2206 every other day	Drug: MK2206 Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 30 mg, 60 mg, 75 mg, and 90 mg on a schedule of once daily every other day in repeating 4 week cycles. Other Name: MK2206
Experimental: QW Schedule MK2206 once weekly	Drug: MK2206 Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 90 mg, 135 mg, 200 mg, 250 mg, and 300 mg on a schedule of once weekly in repeating 4 week cycles. Other Name: MK2206

Eligibility

Criteria

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 normal organ function; is no greater than 2 on the ECOG Performance Scale
Has a negative blood or urine pregnancy test within 72 hours of receiving the first dose of study drug 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 30 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 HIV-positive
Has known history of Hepatitis B or C or active Hepatitis A
Is receiving treatment with oral corticosteroids

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670488

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00670488 History of Changes
Other Study ID Numbers:	2008_513, MK2206-002
Study First Received:	April 29, 2008
Last Updated:	March 6, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013