Nilotinib With Radiation for High Risk Chordoma (NCT01407198) | Clinical Trial Compass
CompletedPhase 1
Nilotinib With Radiation for High Risk Chordoma
United States23 participantsStarted 2011-08
Plain-language summary
The study drug, Nilotinib, is believed to slow down tumor growth by regulating a gene involved in cellular growth of chordoma cells. During this research study, subjects will also receive radiation therapy which is considered a standard treatment for advanced chordomas. It is hoped by adding nilotinib, the benefits of radiation therapy can be enhanced without adding significant toxicities.
The purpose of this research study is to determine the safety of nilotinib when used in combination with radiation therapy, and the highest dose of nilotinib that can be given safely with radiation therapy.
Who can participate
Age range
18 Years
Sex
ALL
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 chordoma
* Considered to have high risk disease
* Measurable disease
* Life expectancy \> 3 months
* Adequate organ function
* Able to swallow oral capsules
Exclusion Criteria:
* Previous treatment with any other tyrosine kinase inhibitor
* Previous treatment with radiotherapy to the primary or recurrent chordomas
* Impaired cardiac function
* Currently receiving treatment with strong CYP3A4 inhibitors
* Requires anticoagulation with coumadin
* Impaired GI function or GI disease that may significantly alter the absorption of study drug
* Acute or chronic pancreatic disease
* Known cytopathologically confirmed CNS infiltration
* Another primary malignant disease which requires systemic treatment
* Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
* History of significant congenital or acquired bleeding disorder unrelated to cancer
* Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery
* Treatment with other investigational agents within 30 days of Day 1
* History of non-compliance to medical regimens
* Pregnant or breast-feeding
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
To determine the dose limiting toxicities (DLTs) for participants when treated above the maximum tolerated dose (MTD).