Conditions: Locally Advanced, Metastatic Solid Tumors
Keywords: Tumors, cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the safety and tolerability of several dose levels of MK-2206 in combination with chemotherapy and targeted therapy agents in participants with locally advanced or metastatic solid tumors.

The primary hypotheses are that administration of MK-2206 in combination with either carboplatin + paclitaxel, docetaxel, or erlotinib in participants with locally advanced or metastatic solid tumors will have acceptable tolerability, a dose limiting toxicity (DLT) rate of ≤30%, plasma exposure and pharmacodynamics that exceed target thresholds, and allow for definition of a maximum tolerated dose (MTD) in each of the 3 combinations.

Detailed description:

Arms:
arm 1: MK-2206 combined with carboplatin and paclitaxel arm 2: MK-2206 combined with docetaxel plus pretreatment with a corticosteroid arm 3: MK-2206 combined with erlotinib

Interventions: intervention 1: MK-2206 intervention 2: docetaxel intervention 3: erlotinib intervention 4: carboplatin intervention 5: paclitaxel intervention 6: corticosteroid
Intervention descriptions: intervention 1: MK-2206 given by mouth (PO) on Days 1, 3, 5, and 7 of each 21-day cycle (30 mg, 45 mg, or 60 mg) OR MK-2206 PO on Day 1 of each 21-day cycle (60 mg, 90 mg, 135 mg, 200 mg , or 250 mg) intervention 2: Administered as an IV infusion on Day 1 of each 21-day cycle intervention 3: Administered daily (QD) PO in each 21-day cycle intervention 4: Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle intervention 5: Administered as an intravenous (IV) infusion on Day 1 of every 21-day cycle intervention 6: Administered PO twice a day (BID) on Days 1-3 of each 21-day cycle

Protocol document: