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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 Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00963547
First received: August 19, 2009
Last updated: March 6, 2012
Last verified: March 2012

August 19, 2009
March 6, 2012
September 2009
August 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Maximum tolerated dose (MTD) of MK2206 in combination with trastuzumab and trastuzumab/lapatinib [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
  • Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: 21 Days ] [ Designated as safety issue: Yes ]
  • Recommended Phase 2 Dose of MK2206 in Combination with Trastuzumab and Trastuzumab/Lapatinib [ Time Frame: 23 Days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00963547 on ClinicalTrials.gov Archive Site
Not Provided
  • Tumor response rate [ Time Frame: From time of first dose of study drugs until the patient discontinues due to disease progression, unacceptable toxicity, or withdrawal of consent ] [ Designated as safety issue: No ]
  • C(max), T(max), C(trough) and AUC for MK2206 [ Time Frame: 23 Days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of MK2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (2206-015)
A Phase I Investigation of the Combination of MK2206, Trastuzumab and Lapatinib in HER2+ Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Breast Cancer
  • 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.
  • 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.
  • Experimental: 1
    Part 1: MK2206 + trastuzumab
    Interventions:
    • Drug: MK2206
    • Biological: Comparator: trastuzumab
  • Experimental: 2
    Part 2: MK2206 + trastuzumab + lapatinib
    Interventions:
    • Drug: Comparator: MK2206
    • Biological: Comparator: trastuzumab
    • Drug: Comparator: lapatinib
Hudis C, Swanton C, Janjigian YY, Lee R, Sutherland S, Lehman R, Chandarlapaty S, Hamilton N, Gajria D, Knowles J, Shah J, Shannon K, Tetteh E, Sullivan DM, Moreno C, Yan L, Han HS. A phase 1 study evaluating the combination of an allosteric AKT inhibitor (MK-2206) and trastuzumab in patients with HER2-positive solid tumors. Breast Cancer Res. 2013 Nov 19;15(6):R110. doi: 10.1186/bcr3577.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00963547
2009_646, MK2206-015
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP