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An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Thyroid Cancer

Thank you

Trial Information

An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer


Inclusion Criteria:



- The subject has a histologically confirmed diagnosis of MTC that is cannot be removed
by surgery, is locally advanced, or has spread in the body.

- The subject is at least 18 years old.

- The subject has an ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.

- The subject has documented worsening of disease (progressive disease) at screening
compared with a previous CT scan or MRI image done within 14 months of screening.

- The subject has recovered from clinically significant adverse events (side effects)
due to any other medications that were administered prior to randomization.

- The subject has adequate organ and bone marrow function.

- Subjects who are sexually active (male and female) must agree to use medically
accepted methods of contraception during the course of the study and for 3 months
following discontinuation of study treatments.

- The subject has no other diagnosis of cancer (unless non-melanoma skin cancer, an
early form of cervical cancer, or another cancer diagnosed ≥ 2 years previously) and
currently has no evidence of malignancy (unless non-melanoma skin cancer or an early
form of cervical cancer).

- Female subjects of childbearing potential must have a negative pregnancy test at
screening.

Exclusion Criteria:

- The subject has received prior treatment for their cancer within 4 weeks of
randomization (6 weeks for nitrosoureas or mitomycin C).

- The subject has received radiation to ≥ 25 % of bone marrow.

- The subject has received treatment with other investigational agents (unapproved
therapies) within 4 weeks of randomization.

- The subject has received treatment with XL184.

- The subject has brain metastases or spinal cord compression, unless completed
radiation therapy ≥ 4 weeks prior to randomization and stable without steroid and
without anti-convulsant treatment for ≥ 10 days.

- The subject has a history of clinically significant episodes of vomiting blood or a
recent history of vomiting > 2.5 mL (about 1/2 teaspoon) of red blood

- The subject has serious illness other than cancer

- The subject is pregnant or breastfeeding.

- The subject has an active infection requiring ongoing treatment.

- The subject is incapable of understanding and complying with the protocol or unable
to provide informed consent.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate progression-free survival (PFS) with XL184 as compared with placebo in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC)

Outcome Time Frame:

Assessed at periodic visits

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

XL184-301

NCT ID:

NCT00704730

Start Date:

June 2008

Completion Date:

March 2013

Related Keywords:

  • Thyroid Cancer
  • Medullary Thyroid Cancer
  • MTC
  • Thyroid Neoplasms
  • Thyroid Diseases

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
University of IowaIowa City, Iowa  52242
Mayo ClinicRochester, Minnesota  55905
University of Colorado Cancer CenterDenver, Colorado  80262
Washington University School of MedicineSaint Louis, Missouri  63110
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Hollings Cancer CenterCharleston, South Carolina  29403
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Stanford Cancer CenterStanford, California  94305-5824
Washington Cancer InstituteWashington, District of Columbia  20010
Oregon Health & Science UniversityPortland, Oregon  97201
Fountain Valley, California  92708
Nebraska Methodist HospitalOmaha, Nebraska  68114
Henry Ford Health SystemDetroit, Michigan  48202
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of ChicagoChicago, Illinois  60637
Kansas University Medical CenterKansas City,, Kansas  66160-7390
UCLALos Angeles, California  90095
Peninsula Cancer InstituteNewport News, Virginia  23601
St. Luke'S Hospital & Health NetworkBethlehem, Pennsylvania  18015
Ohio State University, James Cancer HospitalColombus, Ohio  43210
Yale University, School of MedicineNew Haven, Connecticut  06520
University of Alabama at Birmingham, Comprehensive Cancer CenterBirmingham, Alabama  
TGEN Clinical Research Service at Scottsdale HealthcareScottsdale, Arizona  85258
H. Lee Moffet Cancer Center and Research InstituteTampa, Florida  33612
Capitol Comprehensive Cancer Care Clinic and Research InstituteJefferson City, Missouri  65109
Vermont Cancer Center at Fletcher Allen Health CareBurlington, Vermont  05401