Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer (NCT01347788) | Clinical Trial Compass
CompletedPhase 1
Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer
United States34 participantsStarted 2011-04
Plain-language summary
Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed prostate adenocarcinoma
* Bone metastases confirmed by bone scan
* Current androgen deprivation therapy
* Castration-resistant disease based on progression in bone and/or PSA progression
* Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events
* Life expectancy of greater than 3 months
* Normal organ and marrow function
* Capable of understanding and complying with the protocol requirements
* Agree to use medically accepted methods of contraception
* Able to swallow capsules
Exclusion Criteria:
* More than two prior chemotherapy regimens for metastatic prostate cancer
* Known untreated, symptomatic or uncontrolled brain metastases
* Serious or unhealed wound
* Treatment with anticoagulants
* Previously identified allergy or hypersensitivity to components of the study treatment formulation
* History of a different malignancy unless disease-free for at least 5 years, or basal or squamous cell carcinoma of the skin
* Current antiretroviral therapy
* Uncontrolled hypertension
* Uncontrolled intercurrent illness
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Partial Response in Bone Scan From Baseline to Week 6