Conditions: Solid Tumors
Keywords: Advanced-stage Solid Tumors MM-121 Carboplatin Pemetrexed Gemcitabine Cabazitaxel ErbB3 Phase I Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief summary:
To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

Detailed description:
This study was a Phase 1 and pharmacologic dose-escalation trial of MM-121 in combination with certain anticancer therapies. The dose-escalation portion of the study employed a 3 + 3 design to assess the safety, tolerability, and pharmacokinetics of MM-121 administered weekly in combination with certain anticancer therapies in patients with advanced/recurrent cancer. Doses of MM-121 and/or the anticancer therapy were escalated until either the MTD is identified or the combination was shown to be tolerable at the highest planned doses.

Arms:
arm 1: escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle arm 2: carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle arm 3: pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle arm 4: escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle

Interventions: intervention 1: MM-121 intervention 2: Carboplatin intervention 3: Pemetrexed intervention 4: Cabazitaxel intervention 5: Gemcitabine
Intervention descriptions: intervention 1: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV intervention 2: administered at AUC 6 intervention 3: administered IV at 500 mg/m2 intervention 4: administered IV at 20 mg/m2 or 25 mg/m2 intervention 5: administered IV at 1000 mg/m2 or 1250 mg/m2

Protocol document: