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

Information source: Exelixis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer; Castration Resistant Prostate Cancer; Pain; Prostatic Neoplasms

Intervention: cabozantinib (Drug); mitoxantrone (Drug); prednisone (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Exelixis

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.

Clinical Details

Official title: A Phase 3, Randomized, Double-blind, Controlled Trial of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Confirmed pain response at Week 12 durable since Week 6

Secondary outcome:

Bone scan response

Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Histological or cytological diagnosis of castration resistant prostate cancer (serum

testosterone 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 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:

- Prior treatment with cabozantinib or mitoxantrone.

- 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.

Locations and Contacts

Dublin 24, Ireland

Dublin 7, Ireland

Belfast, United Kingdom

Scottsdale, Arizona 85258, United States

Kelowna, British Columbia V1Y 5L3, Canada

Vancouver, British Columbia V57 4E6, Canada

La Jolla, California 92093, United States

Los Angeles, California 90024, United States

Los Angeles, California 90073, United States

Marina del Rey, California 90292, United States

San Diego, California 92123, United States

San Francisco, California 94115, United States

Santa Barbara, California 93105, United States

Stanford, California 94305, United States

Aurora, Colorado 80012, United States

Littleton, Colorado 80122, United States

Washington, District of Columbia 20037, United States

Bath, England BA1 3NG, United Kingdom

Cambridge, England CB2 0QQ, United Kingdom

Leeds, England LS9 7TF, United Kingdom

London, England W12 0HS, United Kingdom

London, England SE1 9RT, United Kingdom

London, England NW1 2PG, United Kingdom

Manchester, England M20 4BX, United Kingdom

Sutton, England SM2 5PT, United Kingdom

Wirral, England CH63 4JY, United Kingdom

Boca Raton, Florida 33486, United States

Athens, Georgia 30607, United States

Chicago, Illinois 60611, United States

Indianapolis, Indiana 46202, United States

Iowa City, Iowa 52242, United States

Westwood, Kansas 66025, United States

Louisville, Kentucky 40202, United States

New Orleans, Louisiana 70112, United States

Baltimore, Maryland 21231, United States

Detroit, Michigan 48201, United States

Detroit, Michigan 48202, United States

Minneapolis, Minnesota 55455, United States

Tupelo, Mississippi 38801, United States

St. Louis, Missouri 63110, United States

Omaha, Nebraska 68198, United States

Las Vegas, Nevada 89109, United States

New Brunswick, New Jersey, United States

Concord, New South Wales 2139, Australia

Darlinghurst, New South Wales 2010, Australia

Kogarah, New South Wales 2217, Australia

Port Macquarie, New South Wales 2444, Australia

Randwick, New South Wales 2031, Australia

Wahroonga, New South Wales 2076, Australia

Buffalo, New York 14263, United States

New York, New York 10065, United States

New York, New York 10022, United States

New York, New York 10019, United States

Chapel Hill, North Carolina 27516, United States

Durham, North Carolina 27710, United States

Raleigh, North Carolina 27607, United States

Cleveland, Ohio 44195, United States

Oklahoma City, Oklahoma 73104, United States

London, Ontario N6A 4L6, Canada

Toronto, Ontario M5G 2M9, Canada

Toronto, Ontario M4N 3M5, Canada

Pittsburgh, Pennsylvania 15232, United States

Milton, Queensland 4064, Australia

South Brisbane, Queensland 4101, Australia

Woolloongabba, Queensland 4102, Australia

Aberdeen, Scotland AB25 2ZN, United Kingdom

Edinburgh, Scotland EH4 2XU, United Kingdom

Glasgow, Scotland G12 0YN, United Kingdom

Inverness, Scotland RO17, United Kingdom

Watertown, South Dakota 57201, United States

Memphis, Tennessee 38120, United States

Nashville, Tennessee 37203, United States

Dallas, Texas 75246, United States

Round Rock, Texas 78681, United States

Salt Lake City, Utah 84112, United States

Box Hill, Victoria 3128, Australia

Wodonga, Victoria 3690, Australia

Norfolk, Virginia 23502, United States

Seattle, Washington 98104, United States

Subiaco, Western Australia, Australia

Madison, Wisconsin 53705, United States

Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: March 2012
Last updated: February 19, 2015

Page last updated: August 23, 2015

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