Promising drug combo targets rare spine tumor
NCT ID NCT01407198
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested the safety of combining the drug nilotinib with standard radiation therapy for people with high-risk chordoma, a rare bone tumor. The goal was to find the highest safe dose of nilotinib that could be given alongside radiation without causing severe side effects. Twenty-three participants were enrolled to help determine the best dose for future studies.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
23 people
The number who actually took part.
- Start date
-
Aug 2011
- Finished
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Jun 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Other studies related to the condition(s) this trial covers.
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