Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
The main purpose of this study is to evaluate the best dose, safety and side effects of ridaforolimus when given with cetuximab for patients with head and neck, lung and colon cancer that has progressed after initial therapy. A second purpose of this study is to gain preliminary information on whether the combination of ridaforolimus and cetuximab is helpful in treating patients with advanced head and neck cancer

Detailed description:
Patients with advanced NSCLC, colorectal cancer, and head and neck cancer that progressed after at least 1 prior regimen for metastatic disease were eligible. Wild-type K-ras was required in colon cancer. All patients received cetuximab 400 mg/m2 week 1 followed by 250 mg/m2/week. Four dose levels of ridaforolimus were planned: 10mg, 20mg, 30mg, and 40mg daily, 5 days each week, on a 28-day cycle.

Arms:
arm 1: Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression

Interventions: intervention 1: Ridaforolimus
Intervention descriptions: intervention 1: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle

Protocol document: