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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00670488
First received: April 29, 2008
Last updated: February 27, 2014
Last verified: February 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00670488     History of Changes
Other Study ID Numbers: 2206-002, 2008_513
Study First Received: April 29, 2008
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014