MK-2206, Paclitaxel and Trastuzumab in Treating Patients With HER2-overexpressing Solid Tumor Malignancies
NCT01235897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2014-04-17
Summary
The purpose of this study is to test the safety and safest highest dose of an investigational drug called MK-2206 when given in combination with paclitaxel and trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing solid tumor malignancies.
Conditions
Interventions
- DRUG
-
MK-2206
Different dose levels of MK-2206 will studied, and co-administered with paclitaxel and trastuzumab. MK-2206 will be given orally with a starting dose of 135 mg weekly
- DRUG
-
80 mg/m2 weekly - paclitaxel
- DRUG
-
2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of California, San Francisco
lead OTHER
Principal Investigators
-
Jo Chien, MD · University of California, San Francisco
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-03-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-11-30
Countries
- United States
Study Locations
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