A Phase I/II Study of TRC105 in Metastatic Castrate Resistant Prostate Cancer (CRPC)
Status:
Completed
Trial end date:
2015-04-17
Target enrollment:
Participant gender:
Summary
Background:
- Currently, there is no curative therapy for metastatic castrate-resistant prostate
cancer (CRPC), a leading cause of death in men. However, researchers are exploring new
treatments that involve drugs that prevent angiogenesis (the process by which new blood
vessels are formed) and can slow or prevent tumor growth.
- TRC105 is an experimental drug that blocks angiogenesis, and has been studied for
possible use in treating different kinds of cancer. However, it has not been validated
to treat prostate cancer in general or CRPC in particular.
Objectives:
- To determine the effects of TRC105 as a treatment for CRPC
- To determine the safety and effectiveness of TRC105 in treating CRPC
Eligibility:
- Men at least 18 years of age who have been diagnosed with castrate-resistant prostate
cancer for which existing treatments have not been effective.
Design:
- Eligible individuals will have a series of blood and other tests to determine their
suitability for participating in the study.
- Participants will receive intravenous infusions of TRC105 in a 28-day treatment cycle.
Participants will receive i.v. (intravenous) infusions of TRC105 every two weeks on days
1 and 15 of each 28-day cycle (cohorts 1, 2, 3, 5, and 6) and every week on days 1, 8,
15, and 22 of each 28 day cycle (cohort 4).
- Participants will receive different doses of TRC105 depending on when they enter the
study, up to a maximum tolerated dose or optimum treatment dose.
- Frequent blood and urine tests will be performed during treatment, as well as other
tests of cancer progression as directed by the study doctors. Participants will receive
medicines to help prevent possible adverse side effects of TRC105, such as allergic
reaction to the drug.
- Participants will continue treatment with TRC105 until they or the study team decides
that the medication is not beneficial. No additional testing will be required unless
participants discontinue the treatment because of side effects (which the study doctors
will follow until the side effects are resolved).