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Cabozantinib in Treating Men With Hormone-Resistant Prostate Cancer

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
Phase       Pilot

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Research Study Description

This pilot clinical trial studies cabozantinib in treating men with hormone-resistant prostate cancer. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

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)

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

Other exclusion criteria may apply.

Research Study Number       7819
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Prostate Cancer; Solid Tumors

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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