Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

Last updated: April 23, 2018
Sponsor: Exelixis
Overall Status: Terminated

Phase

3

Condition

Prostate Cancer

Prostate Disorders

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT01522443
XL184-306
  • Ages > 18
  • Male

Study Summary

Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan with these agents) or the pain associated with these metastases.

This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histological or cytological diagnosis of castration resistant prostate cancer (serumtestosterone less than 50 ng/dL).

  • Evidence of bone metastasis related to prostate cancer on bone scans.

  • Documented pain from bone metastases that requires opioid narcotic intervention.

  • Adopted a narcotic regimen that consists of one sustained release opioid agent takendaily for chronic pain and one immediate release opioid agent for breakthrough pain.

  • Received prior docetaxel and either abiraterone or MDV3100 treatment and has evidenceof investigator assessed prostate cancer progression on each agent independently.

  • Maintenance of LHRH agonist or antagonist unless treated with orchiectomy.

  • Recovered from toxicities related to any prior treatments, unless the toxicities areclinically non significant or easily manageable.

  • Adequate organ and marrow function.

  • A left-ventricular ejection fraction (LVEF) of >/= 50% assessed by echocardiogram orMUGA (multigated acquisition scan).

  • Capable of understanding and complying with the protocol requirements (includinghaving the ability to access an interactive voice recognition system and self-reportpain and narcotic use) and signed the informed consent form.

  • Sexually active fertile patients and their partners must agree to use medicallyaccepted methods of contraception (eg, barrier methods, including male condom, femalecondom, or diaphragm with spermicidal gel) during the course of the study and for 3months after the last dose of study treatment.

Exclusion

Exclusion Criteria:

  • Prior treatment with cabozantinib or mitoxantrone.

  • Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with anyother type of cytotoxic or investigational anticancer agent in the last 2 weeks.

  • Radiation therapy in the last 4 weeks (includes radiation targeting bone metastases),radionuclide treatment in the last 6 weeks, or radiation therapy to the thoraciccavity (unless radiation targets bone metastases) in the past 3 months.

  • Treatment with serotonergic psychiatric medication(s) in the last 2 weeks (5 weeks forfluoxetine).

  • Known brain metastases or uncontrolled epidural disease.

  • Requires concomitant treatment, in therapeutic doses, with anticoagulants such aswarfarin or warfarin-related agents, heparin, thrombin or FXa (coagulation factor X)inhibitors, or antiplatelet agents (eg, clopidogrel). Low dose aspirin (above low doselevels for cardioprotection per local applicable guidelines), low-dose warfarin (≤ 1mg/day), and prophylactic low molecular weight heparin are permitted.

  • Uncontrolled, significant intercurrent illness including, but not limited to,cardiovascular disorders, gastrointestinal disorders, active infections, non-healingwounds, recent surgery.

  • Clinically significant hematemesis or hemoptysis of > 0.5 teaspoon of red blood, orother signs indicative of pulmonary hemorrhage in the last 3 months, or history ofother significant bleeding in the past 6 months.

  • Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.

  • Corrected QT interval (QTc) > 500 ms in the last 4 weeks.

  • Unable to swallow capsules or tablets or tolerate infusions.

  • Previously-identified allergy or hypersensitivity to components of the study treatmentformulations investigator or designee.

  • History of another malignancy (except non-melanoma skin cancer, adequately treatedstage I colon cancer, superficial transitional carcinoma of the bladder) in the past 2years.

Study Design

Total Participants: 119
Study Start date:
March 01, 2012
Estimated Completion Date:
January 13, 2015

Connect with a study center

  • Concord, New South Wales 2139
    Australia

    Site Not Available

  • Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Port Macquarie, New South Wales 2444
    Australia

    Site Not Available

  • Randwick, New South Wales 2031
    Australia

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  • Wahroonga, New South Wales 2076
    Australia

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  • Milton, Queensland 4064
    Australia

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  • South Brisbane, Queensland 4101
    Australia

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  • Woolloongabba, Queensland 4102
    Australia

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  • Box Hill, Victoria 3128
    Australia

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  • Wodonga, Victoria 3690
    Australia

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  • Subiaco, Western Australia
    Australia

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  • Kelowna, British Columbia V1Y 5L3
    Canada

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  • Vancouver, British Columbia V57 4E6
    Canada

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  • London, Ontario N6A 4L6
    Canada

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  • Toronto, Ontario M5G 2M9
    Canada

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  • Dublin, 24
    Ireland

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  • Bath, England BA1 3NG
    United Kingdom

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  • Cambridge, England CB2 0QQ
    United Kingdom

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  • Leeds, England LS9 7TF
    United Kingdom

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  • London, England W12 0HS
    United Kingdom

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  • Manchester, England M20 4BX
    United Kingdom

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    Rickmansworth, England HA6 2RN
    United Kingdom

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    Slough, England SL2 4HL
    United Kingdom

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  • Sutton, England SM2 5PT
    United Kingdom

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  • Wirral, England CH63 4JY
    United Kingdom

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  • Aberdeen, Scotland AB25 2ZN
    United Kingdom

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  • Edinburgh, Scotland EH4 2XU
    United Kingdom

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  • Glasgow, Scotland G12 0YN
    United Kingdom

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  • Inverness, Scotland RO17
    United Kingdom

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  • Belfast,
    United Kingdom

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  • Scottsdale, Arizona 85258
    United States

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  • La Jolla, California 92093
    United States

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  • Los Angeles, California 90024
    United States

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  • Marina Del Rey, California 90292
    United States

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  • San Diego, California 92123
    United States

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  • San Francisco, California 94115
    United States

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  • Santa Barbara, California 93105
    United States

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  • Stanford, California 94305
    United States

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  • Aurora, Colorado 80012
    United States

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  • Littleton, Colorado 80122
    United States

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  • Washington, District of Columbia 20037
    United States

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  • Boca Raton, Florida 33486
    United States

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  • Athens, Georgia 30607
    United States

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  • Chicago, Illinois 60611
    United States

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  • Indianapolis, Indiana 46202
    United States

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  • Iowa City, Iowa 52242
    United States

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  • Westwood, Kansas 66025
    United States

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  • Louisville, Kentucky 40202
    United States

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  • New Orleans, Louisiana 70112
    United States

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  • Baltimore, Maryland 21231
    United States

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  • Detroit, Michigan 48201
    United States

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    Detrot, Michigan 48201
    United States

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  • Minneapolis, Minnesota 55455
    United States

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  • Tupelo, Mississippi 38801
    United States

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  • Saint Louis, Missouri 63110
    United States

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    St. Louis, Missouri 63110
    United States

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  • Omaha, Nebraska 68198
    United States

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  • Las Vegas, Nevada 89109
    United States

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  • New Brunswick, New Jersey
    United States

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  • Buffalo, New York 14263
    United States

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  • New York, New York 10065
    United States

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  • Chapel Hill, North Carolina 27516
    United States

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  • Durham, North Carolina 27710
    United States

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  • Raleigh, North Carolina 27607
    United States

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  • Cleveland, Ohio 44195
    United States

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  • Oklahoma City, Oklahoma 73104
    United States

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  • Pittsburgh, Pennsylvania 15232
    United States

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  • Watertown, South Dakota 57201
    United States

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  • Memphis, Tennessee 38120
    United States

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  • Nashville, Tennessee 37203
    United States

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  • Dallas, Texas 75246
    United States

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  • Round Rock, Texas 78681
    United States

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  • Salt Lake City, Utah 84112
    United States

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  • Norfolk, Virginia 23502
    United States

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  • Seattle, Washington 98104
    United States

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  • Madison, Wisconsin 53705
    United States

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  • Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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