Open Label Study of Sipuleucel-T

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 91
• Participant gender: Male

Summary

This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dendreon
• Last Updated: 2015-10-05

Criteria

Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.

• Histologically documented adenocarcinoma of the prostate.

• Metastatic disease.

• Castrate resistant prostate cancer.

• Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration.

• Life expectancy of at least 3 months.

• Men >= 18 years of age.

• Adequate hematologic, renal and liver function.

Exclusion Criteria:

A subject will not be eligible for participation in this study if any of the following criteria apply.

• The presence of known lung, liver, or brain metastases.

• Evidence of neuroendocrine or small cell features.

• Eastern Cooperative Oncology Group (ECOG) performance status > 2.

• Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary)

• Imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression.

• Known malignancies other than prostate cancer that are likely to require treatment within six months of registration.

• A requirement for systemic immunosuppressive therapy for any reason.

• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF.

• Any infection requiring parenteral antibiotic therapy or causing fever (temp > 100.5F or > 38.1C) within 1 week prior to registration.

• Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives.

Treatment with any of the following medications or interventions within 28 days of registration:

• Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans.

• Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide).

• External beam radiation therapy or major surgery requiring general anesthetic.

• Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary.

• Chemotherapy.

• Treatment with any other investigational product.