Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
Background: \- Inhibition of angiogenesis has demonstrable antitumor efficacy against castrate-resistant prostate cancer (CRPC). TRC105 is a human/murine chimeric immunoglobulin heavy constant gamma 1 (IgG1) kappa monoclonal antibody that binds to human CD105 (endoglin), thus inhibiting angiogenesis and tumor growth. Data from an ongoing phase I clinical trial suggest that TRC105 is well tolerated with evidence of clinical efficacy in patients with metastatic CRPC. Primary Objectives: \- Define the maximum tolerable dose (MTD) of TRC105 given every one to two weeks. Secondary Objectives: * Define the dose-limiting toxicities and toxicity profile of TRC105 given every one to two weeks * Evaluate time to disease progression, overall response rate and overall survival. * Describe the prostate specific antigen (PSA) response rate to therapy with TRC105 * Characterize the pharmacokinetics of TRC105 * Demonstrate a biologic effect of TRC105 in the patient and, when possible, on the tumor via laboratory evaluation of the molecular markers of angiogenesis before and after drug administration respectively Eligibility: * Progressive, castrate-resistant, metastatic adenocarcinoma of the prostate * Eastern Cooperative Oncology Group (ECOG) less than or equal to 2 Design: \- An initial single-arm, phase I dose escalation study open to all patients with progressive metastatic CRPC. The study will evaluate patients in five cohorts of escalating dose levels. A maximum of 30 patients will be needed to complete the phase I evaluation.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
