Molecular Profiling Protocol (SCRI-CA-001)

A Pilot Study Utilizing Molecular Profiling of Patients' Tumors to Find Potential Targets and Select Treatments for Their Refractory Cancers

This is an open-label, multicenter pilot study in patients with advanced solid tumors.

The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.

To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.

Inclusion Criteria:

• Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.
• Be defined as refractory to the last line of therapy
• Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study

Exclusion Criteria:

• Patients with symptomatic CNS metastasis
• Any previous history of another malignancy within 5 years of study entry
• Uncontrolled intercurrent illness
• Known HIV, HBV, HCV infection
• Pregnant or breast-feeding