Trial Information

Integrated Molecular Profiling in Advanced Cancers Trial

The increasing appreciation and identification of specific somatic mutations and other
genetic aberrations that drive cancers leave us on the threshold of a new era of
"personalized cancer medicine", in which specific biomarkers will be used to direct targeted
agents only to those patients deemed most likely to respond. The potential medical,
scientific and economic benefits of such a personalized approach to cancer therapy are
immense and self-evident. Yet despite some important advances, only a limited number of
approved targeted agents have had their approvals predicated on specific biomarkers of
sensitivity or resistance.

The premises behind personalized cancer medicine include: i) genetic aberrations exist in
human malignancies; ii) a subset of these aberrations, often present across multiple cancer
types, have functional relevance as "hallmarks" or "drivers" for oncogenesis and tumor
progression; iii) such genetic aberrations are potentially "druggable" targets; and iv)
there are tolerable medicinal compounds that can effectively modulate such targets. A key
requirement of this new, personalized approach to anti-cancer therapy is that specific
patients must be matched to a particular drug or combination of drugs. Molecular profiling
of tumors to identify somatic mutations and/or other genetic aberrations are examples of
enrichment strategies to assist in matching patients to drugs or treatments that have gained
increasing interest in the oncology community.

The present protocol seeks to provide molecular profiling data to the treating physician for
patients with advanced breast, non-small cell lung, colorectal, genitourinary,
pancreatobiliary gastrointestinal, upper aerodigestive tract, and gynecological cancers who
are candidates for systemic therapy, as well as patients who are phase I trial candidates,
in order to help identify which standard regimens or clinical trials of molecularly targeted
therapies may be most appropriate for the individual patient.