Clinical Trial Details

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Study ID 7819
Investigator
Celestia Higano,   Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Title Cabozantinib in Treating Men With Castration-Resistant Prostate Cancer
Conditions Adenocarcinoma of the Prostate
Castration-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Interventions Drug: cabozantinib-s-malate
Other: laboratory biomarker analysis
Phase N/A
Purpose 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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 Key Exclusion Criteria
  • 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
  • Study Location
    Seattle Cancer Care Alliance/University of Washington
    Seattle, Washington, 98109
    Contact Celestia S. Higano
    206-288-1136
    Information objtained from ClinicalTrials.gov, on 7/22/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01703065


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