'Phase 0' Trials Aim to Speed Cancer Drug Development

Related Encyclopedia • Adenocarcinoma of the Lung and Brain Metastases • Basal Cell Carcinoma • Bladder Cancer • Bone Cancer More... Related Healthscout Videos Tracking Breast Cancer with Less Pain No More Biopsies? Dealing with Dying 5 Breast Cancer Myths More... Related Animations • Breast Self-Exam Video • Colon Cancer More... Related Drug Information • Epogen • Iressa • Procrit • Topamax More... Related News Articles • Health Tip: If You Notice Blood in the Stools • Pregnancy May Protect Breast Cancer Survivors • Protein in Breast Tumors May Predict Chemo Response • Preventive Mastectomy May Not Lower Risks More...

Page:  << Prev | 1 | 2 | 3 | Next >>

A mere 5 percent of new oncology drug applications submitted to the U.S. Food and Drug Administration get approved, according to the National Cancer Institute. One reason is the lack of systems to predict early on which drugs would be useful and which would have too many side effects, Doroshow explained. In fact, 70 percent of phase II drugs don't make it to the third phase because of a lack of efficacy.

"We need to have a better handle on whether or not they are going to be useful sooner," he added.

To speed up development, the National Cancer Institute established the NCI Experimental Therapeutics (NExT) program, of which phase 0 trials are an integral part.

Text Continues Below

---

The first-ever phase 0 trial involved ABT-888, an oral drug that inhibits an enzyme critical for repairing DNA damage. It's believed that the drug could improve the effectiveness of chemotherapy. Researchers obtained key data within five months of the study's initiation, which helped guide the design of subsequent phase I trials. The findings were published online April 13 in the Journal of Clinical Oncology.

"I think it's going to lay out a very interesting model for other researchers who are also interested in phase 0 studies," said T. Patrick Hill, senior policy fellow at the Edward J. Bloustein School of Planning and Public Policy at Rutgers, and a clinical research ethics consultant at the Cancer Institute of New Jersey, both in New Brunswick.

Experts expect the model to be used for other types of drugs as well.

Phase 0 trials expose people to less toxicity and involve fewer participants -- 10 to 12, on average, versus 20 to 25 in a phase I trial. Trial participants receive only a limited number of doses -- and much lower doses -- over a shorter period of time. However, because small doses of a drug are given for a short period, participants probably will not realize a therapeutic benefit.

Page:  << Prev | 1 | 2 | 3 | Next >>