Cohorts of Docetaxel or Cabazitaxel in Combination With the Potent CYP3A4 Inhibitor, Clarithromycin
Status:
Terminated
Trial end date:
2019-07-26
Target enrollment:
Participant gender:
Summary
This clinical trial is being conducted to recommend a safe and tolerable phase 2 dose of
docetaxel or cabazitaxel when combined with clarithromycin in men who have developed
castrate-resistant prostate cancer.
In the castrate-resistant setting, resistance to taxane therapy inevitably develops. Men who
develop resistance to taxanes have a very poor prognosis, and few treatment options.
It is believed that CYP enzymes contribute to docetaxel and cabazitaxel resistance in
metastatic prostate cancer, and this resistance can be mitigated through pharmacologic CYP
inhibition. In this study a potent CYP3A inhibitor, clarithromycin, will be co-administered
concurrently with either docetaxel or cabazitaxel, whose systemic metabolism is dependent of
CYP3A4, with the intent to overcome resistance to taxanes.
Phase:
Phase 1
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins