Cabozantinib in Men With Castration-Resistant Prostate Cancer (NCT01703065) | Clinical Trial Compass
TerminatedPhase 2
Cabozantinib in Men With Castration-Resistant Prostate Cancer
Stopped: Closed 2017 for low accrual. Last data for primary outcome on 02Feb2015.
United States9 participantsStarted 2013-06-18
Plain-language summary
This pilot clinical trial studies cabozantinib in treating men with castration-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. The subject has a proven histologic diagnosis of prostate adenocarcinoma, but may have undergone prior surgery and/or radiation.
✓. The subject must currently have castration resistant prostate cancer defined as 2 serial rising PSAs with a castrate level of testosterone (\<50 ng/dL).
✓. A subject with non-metastatic CRPC may not have received prior chemotherapy unless in the neoadjuvant or adjuvant setting \> 24 months ago and may not have received prior zoledronic acid or denosumab.
✓. A subject with metastatic CRPC must have bone metastases accessible for biopsy by CT guidance.
✓. The subject must be willing to undergo sequential biopsy of bone or bone metastases.
✓. Subjects must have discontinued additional hormonal (eg bicalutamide, abiraterone, estrogen) therapy prior to the first dose of cabozantinib. No antiandrogen withdrawal period is required.
✓. Subjects previously treated on another investigational agent must have a 2-week or more washout before starting cabozantinib, depending on the agent, toxicity profile, and half-life. However, such patients may begin tetracycline dosing after consent is signed.
✓. Subjects who are currently on GnRH agonists or antagonist therapy must continue androgen suppression.
Exclusion criteria
✕. The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) within 3 weeks, or nitrosoureas/ mitomycin C within 6 weeks before the first dose of study treatment.
What they're measuring
1
Change in Urinary N-telopeptide (uNTX) as a Marker of Bone Metabolism in Non-metastatic Patients
✕. Prior treatment with cabozantinib and other met inhibitors.
✕. Prior treatment with a small molecule kinase inhibitor or a hormonal therapy (including investigational kinase inhibitors or hormones) within 14 days or five half-lives of the compound or active metabolites, whichever is longer, or before the first dose of study treatment.
✕. The subject has received radiation therapy:
✕. to the thoracic cavity or gastrointestinal tract within 3 months of the first dose of study treatment.
✕. to bone or brain metastasis within 14 days of the first dose of study treatment.
✕. to any other site(s) within 28 days of the first dose of study treatment.
✕. The subject has received radionuclide treatment within 6 weeks of the first dose of study treatment.