Study of AUY922 and Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer

Inclusion Criteria:

Histologically or cytologically confirmed colorectal cancer
KRAS wild type metastatic colorectal cancer
Progression of disease on at least 2 prior therapy to have included 5FU, or oxaliplatin or bevacizumab or irinotecan
Prior treatment with cetuximab is allowed (full dose tolerated), provided that the patient never required a dose reduction due to toxicities
Must have at least one measurable lesion
Must be 18 years of age or older
ECOG performance status 0-1
Life expectancy must be greater than 12 weeks
For women of childbearing potential, a negative pregnancy blood test must be obtained less than 3 days prior to the first AUY922 infusion

Exclusion Criteria:

Colorectal cancer with a KRAS mutation or in which the KRAS genotype status is unknown
Metastasis to the CNS
Prior treatment with any Hsp90 inhibitor compounds

Patients who received systemic anti-cancer treatment prior to the first dose of AUY922 within the following time frames:

Radiotherapy, conventional chemotherapy: within 2 weeks
Palliative radiotherapy: within 2 weeks
Nitrosoureas, monoclonal antibodies, such as trastuzumab and mitomycin: within 6 weeks
Any continuous-dosing (i.e. daily dosing, every-other-day dosing, Monday-Wednesday-Friday dosing, weekly etc.) of systemic anti-cancer treatment for which the recover period is not known, or investigational drugs (i.e. targeted agents) within a duration of ≤ 5 half lives of the agent and their active metabolites (if any)
Treatment of therapeutic doses of coumadin-type anticoagulants. [Maximum daily dose of 2mg, for line patency permitted]
Known sensitivity to cetuximab
Unresolved ≥ grade 1 diarrhea
Malignant ascites that require invasive treatment
Concurrent medications that are substrates, inhibitors or inducers of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 and cannot be switched or discontinued or switched to an alternative drug prior to commencing AUY922 dosing need special consideration on a case by case basis
Major surgery ≤ 2 weeks prior to randomization or who have not recovered from such therapy
Impaired cardiac function