phase I trial


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phase I trial

, phase 1 trial
A clinical trial to determine the toxicity of a new drug. Such trials test safety and maximum dosage, help researchers discover the best way to administer a treatment (orally or intravenously) and the most appropriate dosage. Phase I trials also help to discover potentially harmful adverse effects of a new treatment. Even though the trial is not designed to show whether the treatment is effective, since an experimental drug is chosen for its promise, the patient may still benefit. Only a small number of patients are included (15 to 25 who have not been helped by other treatments), and there usually is no control group.
See also: trial
References in periodicals archive ?
Cougar's oncology portfolio includes CB7630, a targeted inhibitor of the 17alpha-hydroxylase/C17,20 lyase enzyme which is currently being tested in a Phase II clinical trial in prostate cancer; CB3304, an inhibitor of microtubule dynamics which is currently in a Phase I trial in hematological malignancies and CB1089, an analog of vitamin D which has been clinically tested in a number of solid tumor types.
Conclude the recently started Phase I trial of the combination of eniluracil and 5-FU in patients with solid tumors in the third quarter of 2006 to provide optimal dose, schedule and safety data for the combination based on Adherex's proprietary approach.
With three phase I trials so soon after initiating operations, ZIOPHARM is delivering on its promise to deliver novel cancer therapies in a timely fashion," commented Jonathan Lewis, MD, PhD, Chief Executive Officer of ZIOPHARM.
The study schedule used in this Phase I trial was used as one of the schedules for the first step of the ongoing randomized two-step Phase II combination study with interferon in metastatic renal cancer, described above, which began in the fourth quarter of2004.