Prostate Cancer
Conditions
Keywords
Hormone Refractory Metastatic Prostate Cancer
Brief summary
This is a multi-center, open-label, dose finding study of CV787 adenovirus in patients with hormone refractory metastatic prostate cancer. Patients will receive treatment intravenously at one of up to nine dose levels, each containing three to six patients.
Interventions
BIOLOGICALCV787 (CG7870)
Sponsors
Cell Genesys
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety, tolerability, and the maximum tolerated dose of CG7870 when administered intravenously to patients with progressive metastatic hormone refractory prostate cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate prostate-specific antigen (PSA) response rates, duration of response, and time to disease progression | — |
| To evaluate other clinical efficacy responses observed | — |
| To evaluate the systemic pharmacokinetics of CG7870 after intravenous administration | — |
| To monitor the immune response to CG7870 | — |
Outcome results
None listed