Conditions: Advanced Solid Tumors Tumors Cancer
Keywords: Neoplasms Paclitaxel Trastuzumab
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 17
Healthy volunteers: no

Brief 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.

Detailed description:
The purpose of this study is to determine the safety and maximum tolerated dose (MTD) of MK-2206 in combination with paclitaxel and trastuzumab when given to patients with HER2-overexpressing solid tumor malignancies. MK-2206 is an oral drug (taken by mouth) that turns off a protein called AKT inside cancer cells. This could be helpful in treating treatment-resistant cancers, because AKT allows cells to survive despite active anticancer treatment. In the case of HER2-positive cancers, laboratory studies suggest that the drug combination of MK-2206 and paclitaxel and trastuzumab may be effective.

Arms:
arm 1: None

Interventions: intervention 1: MK-2206 intervention 2: Paclitaxel intervention 3: Trastuzumab
Intervention descriptions: intervention 1: 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 intervention 2: 80 mg/m2 weekly - paclitaxel intervention 3: 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab

Protocol document: