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Cabozantinib in Treating Men With Castration-Resistant Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Prostate Cancer Foundation
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01703065
First received: October 5, 2012
Last updated: June 14, 2017
Last verified: June 2017
October 5, 2012
June 14, 2017
June 18, 2013
February 18, 2019   (Final data collection date for primary outcome measure)
Change in urinary N-telopeptide (uNTX) [ Time Frame: Baseline and 6 weeks ]
Will be analyzed after log-transformation.
Same as current
Complete list of historical versions of study NCT01703065 on ClinicalTrials.gov Archive Site
  • Toxicity assessed using CTCAE version 4.0 [ Time Frame: Up to 4 weeks post-treatment ]
    Toxicity will be described by grade and frequency.
  • Progression-free survival [ Time Frame: Up to 4 weeks post-treatment ]
    Kaplan-Meier methods will be used to report progression-free survival.
  • Time to progression [ Time Frame: From date of registration to date of progressive disease, assessed up to 4 weeks post-treatment ]
    Kaplan-Meier methods will be used to report time to progression.
  • Objective response [ Time Frame: Up to 4 weeks post-treatment ]
    Proportions and 95% binomial confidence intervals will be reported for objective response.
  • PSA response [ Time Frame: Up to 4 weeks post-treatment ]
    Proportions and 95% binomial confidence intervals will be reported for PSA response.
  • Duration of response [ Time Frame: Up to 4 weeks post-treatment ]
    Mean and the corresponding standard deviation will be used to describe the duration of response among responders.
  • Changes in dynamic histomorphometry of involved and uninvolved bone [ Time Frame: Baseline and 6 weeks ]
    Logistic models will be used.
  • Changes in bone and serum markers of bone metabolism [ Time Frame: Baseline, 6 weeks and 12 weeks ]
    Will be explored using a linear mixed model to determine if there is a difference in these markers over time between patients with progressive disease and those without.
  • Toxicity assessed using CTCAE version 4.0 [ Time Frame: Up to 4 weeks post-treatment ]
    Toxicity will be described by grade and frequency.
  • Progression-free survival [ Time Frame: Up to 4 weeks post-treatment ]
    Kaplan-Meier methods will be used to report progression-free survival.
  • Time to progression [ Time Frame: From date of registration to date of progressive disease, assessed up to 4 weeks post-treatment ]
    Kaplan-Meier methods will be used to report time to progression.
  • Objective response [ Time Frame: Up to 4 weeks post-treatment ]
    Proportions and 95% binomial confidence intervals will be reported for objective response.
  • PSA response [ Time Frame: Up to 4 weeks post-treatment ]
    Proportions and 95% binomial confidence intervals will be reported for PSA response.
  • Duration of response [ Time Frame: Up to 4 weeks post-treatment ]
    Mean and the corresponding standard deviation will be used to describe the duration of response among responders.
  • Changes in dynamic histomorphometry of involved and uninvolved bone [ Time Frame: Baseline and 12 weeks ]
    Logistic models will be used.
  • Changes in bone and serum markers of bone metabolism [ Time Frame: Baseline and 6 weeks ]
    Will be explored using a linear mixed model to determine if there is a difference in these markers over time between patients with progressive disease and those without.
  • Changes in MET, AKT, FASN and VEGFR expression and phosphorylation status (activation) in osteoblasts or osteoclasts and prostate cancer cells from bone biopsy specimens [ Time Frame: Baseline and 6 weeks ]
    Will be explored using a linear mixed model to determine if there is a difference in these markers over time between patients with progressive disease and those without.
Not Provided
Not Provided
 
Cabozantinib in Treating Men With Castration-Resistant Prostate Cancer
A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and the Microenvironment in Men With Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer
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.

PRIMARY OBJECTIVES:

I. To assess the impact of cabozantinib on markers of bone turnover and microenvironment in men with non-metastatic castration-resistant prostate cancer and to compare the findings in men with metastatic castration-resistant prostate cancer.

SECONDARY OBJECTIVES:

I. To describe the associated changes in dynamic histomorphometry at baseline and after 6 weeks of cabozantinib therapy in men with non-metastatic castration-resistant prostate cancer.

II. To characterize, describe, and compare the effects of cabozantinib in men with non-metastatic and metastatic bone disease with respect to the following measurements at baseline and on therapy: markers of bone metabolism in blood including bone specific alkaline phosphatase, alkaline phosphatase, lactate dehydrogenase (LDH); changes in markers of apoptosis, proliferation, and angiogenesis in biopsy specimens from both bone and soft tissue during therapy with cabozantinib.

TERTIARY OBJECTIVES:

I. Radiographic disease responses and toxicities will be monitored for all patients.

OUTLINE:

Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adenocarcinoma of the Prostate
  • Castration-resistant Prostate Cancer
  • Recurrent Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • Drug: cabozantinib-s-malate
    Given PO
    Other Names:
    • BMS-907351
    • Cometriq
    • XL184
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Treatment (cabozantinib)
Patients receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: cabozantinib-s-malate
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9
April 1, 2019
February 18, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01703065
7819
NCI-2012-01898 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Washington
University of Washington
  • Prostate Cancer Foundation
  • National Cancer Institute (NCI)
Principal Investigator: Celestia Higano Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP