Status:
COMPLETED
Efficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid Cancer
Lead Sponsor:
Exelixis
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or me...
Eligibility Criteria
Inclusion
- The subject has a histologically confirmed diagnosis of MTC that 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2020
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00704730
Start Date
June 1 2008
End Date
September 1 2020
Last Update
April 20 2021
Active Locations (113)
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1
University of Alabama at Birmingham, Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
TGEN Clinical Research Service at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
3
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Burbank, California, United States, 91505