Infinity and MedImmune start Phase II prostate cancer drug trial

The goal of this open-label, multi-center study is to determine the anti-tumor activity of IPI-504 in patients with hormone-refractory prostate cancer (HRPC), also referred to as castration-resistant prostate cancer, and to correlate prior treatment status with clinical response. Two groups of patients will be enrolled – one group having no prior treatment with cytotoxic chemotherapy, and one group having had prior treatment with a Taxotere (docetaxel)-based chemotherapy.

In this study, IPI-504 will be administered by intravenous infusion at the recommended Phase II dose of 400mg/m2 on a three-week cycle of therapy, consisting of twice-weekly treatment for two weeks followed by one week off. Evidence of biological activity in both groups of patients will be evaluated by RECIST (response evaluation criteria in solid tumors) and measurement of prostate-specific antigen levels.

The trial is expected to enroll 30 patients initially (15 per group) and will expand to enroll an additional 10 patients in each trial arm if a response is observed in at least one patient in that arm.

This study marks the third solid tumor indication in which IPI-504 is being evaluated. Enrollment has commenced at San Bernardino Urological Associates Medical Group in San Bernardino, California and the study is expected to expand to additional sites including the Dana-Farber Cancer Institute (DFCI), the Massachusetts General Hospital and the Beth-Israel Deaconess Medical Center in Boston, Massachusetts.

William Oh, clinical director, Lank Center for Genitourinary Oncology, DFCI, and the trial’s principal investigator, said: “Hormone-refractory prostate cancer is a deadly disease with few effective therapeutic options for patients, particularly after docetaxel-based chemotherapy. This trial is an important opportunity to assess the impact that IPI-504 may have on delaying disease progression for patients with HRPC.”