A Study of MK2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (2206-015)
|ClinicalTrials.gov Identifier: NCT00963547|
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : February 4, 2015
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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 or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors Breast Cancer||Drug: MK2206 Drug: Comparator: MK2206 Biological: Comparator: trastuzumab Drug: Comparator: lapatinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Investigation of the Combination of MK2206, Trastuzumab and Lapatinib in HER2+ Solid Tumors|
|Study Start Date :||September 2009|
|Primary Completion Date :||August 2011|
|Study Completion Date :||December 2011|
Part 1: MK2206 + trastuzumab
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.
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.
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 ]
- Characterize safety and tolerability of MK2206 by monitoring incidence rate of adverse experiences [ Time Frame: study duration ]
- Recommended Phase 2 Dose of MK2206 in Combination with Trastuzumab and Trastuzumab/Lapatinib [ Time Frame: study duration ]
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