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Study ID
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7819
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Investigator
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Celestia Higano, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Title
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Cabozantinib in Treating Men With Castration-Resistant Prostate Cancer
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Conditions
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Adenocarcinoma of the Prostate
Castration-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
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Interventions
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Drug: cabozantinib-s-malate
Other: laboratory biomarker analysis
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Phase
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N/A
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Purpose
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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.
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Eligibility
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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
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Study Location
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N/A
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Contact
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Celestia S. Higano
206-288-1136
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Information obtained from ClinicalTrials.gov, on
6/18/2013. 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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