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Complete title: A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and Microenvironment in Men With Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer
|Research Study Number||7819|
|Principal Investigator||Tia Higano, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Male
Key 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 prostate-specific antigens (PSAs) with a castrate level of testosterone (< 50 ng/dL)
- A subject with non-metastatic castration-resistant prostate cancer (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 computed tomography (CT) guidance
- The subject must be willing to undergo sequential biopsy of bone or bone metastases
- Adequate organ and bone marrow function.
- The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Prior treatment with cabozantinib and other met inhibitors
- Cytotoxic chemotherapy or biologic agents within 3 weeks of study treatment
- Recent radiation therapy (3 months for thoracic cavity, 14 days for bone or brain metastasis, 28 days for other sites) or radionuclide treatment within 6 weeks of starting study drug.
- The subject has received any other type of investigational agent within 28 days before the first dose of study treatment
- The subject has not recovered from toxicities due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
- The subject has primary brain tumor or active brain metastases or epidural
- Coagulation tests need to be adequate for the study
- The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or Factor Xa inhibitors, or antiplatelet agents (eg, clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted
- The subject requires chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's Wort)
- History of clinically significant gastrointestinal bleeding
- The subject has uncontrolled, significant intercurrent or recent illness
- The subject is unable to swallow tablets
- The subject has a corrected QT interval (QTcF) > 500 ms within 28 days before day 1 of cycle 1
- The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation or to tetracycline
Other exclusion criteria may apply.
Prostate Cancer; Solid Tumors
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