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A Study of MK2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (2206-015)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00963547
First received: August 19, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

This study will find the maximum tolerated dose of MK2206 in combination with both trastuzumab and trastuzumab/lapatinib in patients with HER2+ breast cancer and other solid tumors.


Condition Intervention Phase
Advanced Solid Tumors
Breast Cancer
 Drug: MK2206
Drug: Comparator: MK2206
Biological: Comparator: trastuzumab
Drug: Comparator: lapatinib
 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 Investigation of the Combination of MK2206, Trastuzumab and Lapatinib in HER2+ Solid Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Incidence of Dose-Limiting Toxicities (DLTs) and Maximum tolerated dose (MTD) of MK2206 in combination with Trastuzumab and Trastuzumab/Lapatinib [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
  • Characterize safety and tolerability of MK2206 by monitoring incidence rate of adverse experiences [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
  • Recommended Phase 2 Dose of MK2206 in Combination with Trastuzumab and Trastuzumab/Lapatinib [ Time Frame: study duration ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Part 1: MK2206 + trastuzumab
 Drug: MK2206
Part 1: MK2206 tablets will be given starting at a dose of 45 mg every other day and escalated to 60 mg if tolerated OR starting at a dose of 135 mg weekly and escalated to 200 mg weekly if tolerated. Dose reduction to 30mg every other day or 90 mg weekly may be permitted. The dose of MK2206 will be increased or decreased as required to find the maximum tolerated dose of MK2206 for both the every other day and weekly dosing schedules in combination with trastuzumab. The Part 2 dosing level and schedule of MK2206 will be chosen from the maximum tolerated dose of either the every other day or weekly dosing schedules depending on the toxicity profile and preliminary efficacy.
Biological: Comparator: trastuzumab
Trastuzumab will be administered as a 90-minute intravenous infusion at a loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks.
Experimental: 2
Part 2: MK2206 + trastuzumab + lapatinib
 Drug: Comparator: MK2206
Part 2: The maximum tolerated dose of MK2206 determined in Part 1 will be administered in combination with trastuzumab and lapatinib to determine the maximum tolerated dose of the three-drug combination.
Biological: Comparator: trastuzumab
Trastuzumab will be administered as a 90-minute intravenous infusion at a loading dose of 8 mg/kg followed by 6 mg/kg every 3 weeks.
Drug: Comparator: lapatinib
Lapatinib tablets will be administered orally in doses of 500 mg, 750 mg, or 1000 mg.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has a histologically or cytologically-confirmed locally advanced or metastatic HER2+ solid tumor
  • Female patients have a negative pregnancy test
  • Patient is able to swallow tablets

Exclusion Criteria:

  • Patient has had chemotherapy, radiotherapy or biological therapy within 4 weeks of screening. Patients who were receiving trastuzumab and/or lapatinib prior to screening must be off both medications for 1 week prior to first dose of MK2206 if trastuzumab had been administered at 2 mg/kg weekly and 3 weeks if trastuzumab had been administered at 6 mg/kg weekly
  • Patient has primary CNS tumor or known active CNS metastases
  • Patient has a history or evidence of heart disease
  • Patient has poorly controlled high blood pressure or diabetes
  • Patient is pregnant or breastfeeding or is expecting to conceive or father children during the study
  • Patient is HIV positive
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00963547     History of Changes
Other Study ID Numbers: 2009_646, MK2206-015
Study First Received: August 19, 2009
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Documented to be HER2+

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Trastuzumab
Lapatinib
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013