Conditions: Metastatic Colorectal Cancer
Keywords: refractory metastatic colorectal cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the maximum tolerated dose (MTD) of the combination of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal cancer.

Detailed description:

Arms:
arm 1: combination of OSI-906 and everolimus

OSI-906: 50 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days arm 2: combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 10mg Daily, cycle-28 days arm 3: combination of OSI-906 and everolimus

OSI-906: 100 mg Twice a Day, cycle-28 days

Everolimus: 5mg Daily, cycle-28 days

Interventions: intervention 1: OSI-906 intervention 2: Everolimus
Intervention descriptions: intervention 1: Dose Level 1: 50 mg Twice a Day, cycle-28 days Dose Level 2: 100 mg Twice a Day, cycle-28 days Dose Level 2a: 100 mg Twice a Day, cycle-28 days intervention 2: Dose Level 1: 5mg Daily, cycle-28 days Dose Level 2: 10mg Daily, cycle-28 days Dose Level 2a: 5mg Daily, cycle-28 days

Protocol document: