Title A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate-Resistant Prostate Cancer
Principal Investigator Roberto Pili, MD
Study Number 190210
Summary Patients will be randomized to receive either tasquinimod or placebo. Patients will be titrated from a minimum dose of 0.25 mg/day to 0.5 mg/day to a maximum dose of 1 mg/day. During the titration period patients will return to the clinic every 2 weeks. Once a patients individual tolerable daily dose is identified they will continue at that dose level and return to the clinic for monthly visits and assessments. Patients may continue on study treatment for as long as they are tolerating the treatment or until disease progression.
- At least 18 years old and able to swallow oral medication
- Histologically confirmed adenocarcinoma of the prostate with evidence of bone metastatic disease
- Evidence of progressive disease after castration levels of testosterone have been achieved
- Acceptable laboratory values
- No evidence (within 5 years) of prior Malignancies.
- Prior cytotoxic chemotherapy for the treatment of prostate cancer within 2 years will NOT BE eligible
- Patients having had previous anticancer therapy using radiation or specific treatments within 4 weeks may not be eligible to participate in this study
- Any patient who in the opinion of the investigator should not participate in the study will not be eligible for this study.