Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer
NCT ID: NCT01522443
Last Updated: 2018-05-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
119 participants
INTERVENTIONAL
2012-03-31
2015-01-13
Brief Summary
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This study will evaluate the effect of cabozantinib versus mitoxantrone plus prednisone on pain response and bone scan response in men with CRPC.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cabozantinib
Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.
There will be a maximum of 10 infusions for mitoxantrone placebo.
cabozantinib
Tablets taken orally once daily.
Mitoxantrone/prednisone
Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.
There will be a maximum of 10 infusions for mitoxantrone.
mitoxantrone
Given by IV once every 3 weeks.
prednisone
Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
Interventions
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cabozantinib
Tablets taken orally once daily.
mitoxantrone
Given by IV once every 3 weeks.
prednisone
Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
Eligibility Criteria
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Inclusion Criteria
* 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 taken daily for chronic pain and one immediate release opioid agent for breakthrough pain.
* Received prior docetaxel and either abiraterone or MDV3100 treatment and has evidence of 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 are clinically non significant or easily manageable.
* Adequate organ and marrow function.
* A left-ventricular ejection fraction (LVEF) of \>/= 50% assessed by echocardiogram or MUGA (multigated acquisition scan).
* Capable of understanding and complying with the protocol requirements (including having the ability to access an interactive voice recognition system and self-report pain and narcotic use) and signed the informed consent form.
* Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 3 months after the last dose of study treatment.
Exclusion Criteria
* Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other 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 thoracic cavity (unless radiation targets bone metastases) in the past 3 months.
* Treatment with serotonergic psychiatric medication(s) in the last 2 weeks (5 weeks for fluoxetine).
* Known brain metastases or uncontrolled epidural disease.
* Requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or FXa (coagulation factor X) inhibitors, or antiplatelet agents (eg, clopidogrel). Low dose aspirin (above low dose levels for cardioprotection per local applicable guidelines), low-dose warfarin (≤ 1 mg/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-healing wounds, recent surgery.
* Clinically significant hematemesis or hemoptysis of \> 0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other 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 treatment formulations investigator or designee.
* History of another malignancy (except non-melanoma skin cancer, adequately treated stage I colon cancer, superficial transitional carcinoma of the bladder) in the past 2 years.
18 Years
MALE
No
Sponsors
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Exelixis
INDUSTRY
Responsible Party
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Locations
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Scottsdale, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Marina del Rey, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Stanford, California, United States
Aurora, Colorado, United States
Littleton, Colorado, United States
Washington D.C., District of Columbia, United States
Boca Raton, Florida, United States
Athens, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Westwood, Kansas, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Pittsburgh, Pennsylvania, United States
Watertown, South Dakota, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Round Rock, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Concord, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Kogarah, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Randwick, New South Wales, Australia
Wahroonga, New South Wales, Australia
Milton, Queensland, Australia
South Brisbane, Queensland, Australia
Woolloongabba, Queensland, Australia
Box Hill, Victoria, Australia
Wodonga, Victoria, Australia
Subiaco, Western Australia, Australia
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Dublin, , Ireland
Dublin, , Ireland
Bath, England, United Kingdom
Cambridge, England, United Kingdom
Leeds, England, United Kingdom
London, England, United Kingdom
London, England, United Kingdom
London, England, United Kingdom
Manchester, England, United Kingdom
Metropolitan Borough of Wirral, England, United Kingdom
Sutton, England, United Kingdom
Aberdeen, Scotland, United Kingdom
Edinburgh, Scotland, United Kingdom
Glasgow, Scotland, United Kingdom
Inverness, Scotland, United Kingdom
Belfast, , United Kingdom
Countries
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References
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Thanarajasingam G, Basch E, Mead-Harvey C, Bennett AV, Mazza GL, Schwab G, Roydhouse J, Rogak LJ, Dueck AC. An Exploratory Analysis of the "Was It Worth It?" Questionnaire as a Novel Metric to Capture Patient Perceptions of Cancer Treatment. Value Health. 2022 Jul;25(7):1081-1086. doi: 10.1016/j.jval.2021.11.1368. Epub 2022 Jan 3.
Mazza GL, Petersen MM, Ginos B, Langlais BT, Heon N, Gounder MM, Mahoney MR, Zoroufy AJ, Schwartz GK, Rogak LJ, Thanarajasingam G, Basch E, Dueck AC. Missing data strategies for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in Alliance A091105 and COMET-2. Qual Life Res. 2022 Apr;31(4):1069-1080. doi: 10.1007/s11136-021-02968-1. Epub 2021 Aug 21.
Basch E, Becker C, Rogak LJ, Schrag D, Reeve BB, Spears P, Smith ML, Gounder MM, Mahoney MR, Schwartz GK, Bennett AV, Mendoza TR, Cleeland CS, Sloan JA, Bruner DW, Schwab G, Atkinson TM, Thanarajasingam G, Bertagnolli MM, Dueck AC. Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Clin Trials. 2021 Feb;18(1):104-114. doi: 10.1177/1740774520975120. Epub 2020 Dec 1.
Dueck AC, Scher HI, Bennett AV, Mazza GL, Thanarajasingam G, Schwab G, Weitzman AL, Rogak LJ, Basch E. Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial. JAMA Oncol. 2020 Feb 1;6(2):e193332. doi: 10.1001/jamaoncol.2019.3332. Epub 2020 Feb 13.
Other Identifiers
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XL184-306
Identifier Type: -
Identifier Source: org_study_id
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