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A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Castration Resistant Prostate Cancer, Pain, Prostatic Neoplasms

Thank you

Trial Information

A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100


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.

- Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either
abiraterone or MDV3100 treatment and has evidence of 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.

- Capable of understanding and complying with the protocol requirements 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.

- 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 within 4 weeks (excluded if to mediastinum) or radionuclide treatment
within 6 weeks of randomization.

- Liver or brain metastases or cranial epidural disease.

- Requires concomitant treatment, in therapeutic doses, with anticoagulants
antiplatelet agents.

- Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone,
phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St.
John's Wort).

- 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, 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.

- QTcF > 500 ms within 7 days of randomization.

- Unable to swallow capsules or tablets.

- Previously-identified allergy or hypersensitivity to components of the study
treatment formulations.

- Another diagnosis of malignancy requiring systemic treatment in the last 5 years.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

Through 21 months after study start

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

XL184-307

NCT ID:

NCT01605227

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Castration Resistant Prostate Cancer
  • Pain
  • Prostatic Neoplasms
  • prostate cancer
  • castration resistant prostate cancer
  • bone pain
  • CRPC
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Bettendorf, Iowa  52722
Alexandria, Minnesota  56308
Albany, Georgia  31701
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Little Rock, Arkansas  72205-7199
Kansas City, Kansas  66160
Scarborough, Maine  04074
Omaha, Nebraska  68114
Hackensack, New Jersey  07601
Anchorage, Alaska  
Denver, Colorado  
Baltimore, Maryland  21287
Boston, Massachusetts  
Charlotte, North Carolina  
Eugene, Oregon  
South Burlington, Vermont  
Milwaukee, Wisconsin  
Charleston, South Carolina  
Bismarck, North Dakota  58501
Salt Lake City, Utah  84112