Phase 1 Clinic

Phase I Clinical Trials

The Angeles Clinic and Research Institute is proud to offer patients multiple options for extended care through its Phase I Program. Phase I clinical trials are the first stage of testing of novel anticancer therapy in patients. This phase includes clinical trials designed to assess the safety (pharmacovigilance), tolerability, and physiological interactions of a drug and are often conducted in an inpatient clinic, where patients can be observed by full-time staff. In a Phase I trial, the MTD (maximal tolerated dose) is determined using a dose-escalation scheme, in which consecutively enrolled patient cohorts (groups) receive increasing doses of study agent until unmanageable or unsafe side effects emerge.

To safely assess new drugs, cancer patients in initial cohorts of Phase I oncology clinical studies receive low drug doses. Doses are successively increased until the maximum tolerated dose (MTD) is determined. Because traditional chemotherapy is often more effective near the MTD, ethical concerns have been raised about administration of low drug doses to Phase I patients. However, a substantial portion of oncology clinical trials now investigate targeted agents that work by exploiting some feature or pathway that is unique to or exaggerated in cancer cells such as a growth factor receptor, kinase, or angiogenesis pathway. These pathways have different dose-response relationships than traditional chemotherapies. Recent studies have shown that patients who receive low drug doses on novel Phase I oncology trials utilizing immunotherapeutic and targeted agents have similar rates of response due to this different dose response relationships than cytotoxic chemotherapies. (Clin Cancer Res; 16(4); 1289–97)

Critical to the development of novel anticancer treatments is the study on new drugs and drug combinations in clinical trials. Phase I trials perform this function magnificently. Due to the nature of their design, they allow patients with many different types of diagnosis to participate. This allows patients who may have exhausted traditional options for therapy to continue the fight against their cancer. Remarkably, this process has lead to the discovery of certain therapies for select tumor types that would not have been discovered without a Phase I clinical trial.