Study of 2 Different Doses of Revlimid in Biochemically Relapse Prostate Cancer
Status:
Completed
Trial end date:
2016-06-29
Target enrollment:
Participant gender:
Summary
The primary objectives of the study are:
- To evaluate feasibility, safety and tolerance of 6 months administration of Revlimid at
5mg/day and 25mg/day, given orally in subjects with prostate cancer with evidence of
biochemical relapse (M0) following local treatment (i.e., surgery or radiation).
- To assess the rate of PSA (prostatic specific antigen) progression at 6 months after
treatment with 5mg/day and 25mg/day of Revlimid (CC-5013) in patients with evidence of
biochemical relapse after local therapy.
The secondary objectives of the study are:
- To provide preliminary assessments on the effects of Revlimid (CC-5013) at 5mg/day and
25mg/day on various PSA constructs in the subject population (i.e., PSADT [Prostatic
Specific Antigen Doubling Time] and PSA slope) by comparing pre and post treatment
patterns in each arm.
- To evaluate preliminary pharmacodynamic correlations between serum revlimid
concentrations and toxicity, PSA constructs and other evidence of disease progression.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins