Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

Dendreon

Status and phase: Completed; Phase 2

Conditions: Metastatic Androgen Independent Prostate Cancer

Treatments: Biological: APC8015F

Study type: Interventional

Funder types: Industry

Identifiers

NCT00849290

PB01

Details and patient eligibility

About

This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)

Enrollment: 113 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Objective disease progression
• Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)

Exclusion criteria

• Infection requiring IV antibiotics
• Treatment with anticancer interventions within 14 days prior to enrollment
• Any medical condition which could compromise the study's objectives (discretion from sponsor)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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113 participants in 1 patient group

APC8015F

Experimental group

Treatment:

Biological: APC8015F