Status:
COMPLETED
Nilotinib With Radiation for High Risk Chordoma
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Chordoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 th...
Detailed Description
Nilotinib will be taken orally daily in two cycles of 28 days each. Two weeks after taking nilotinib, subjects will begin radiation therapy. Radiation therapy will continue every weekday until Day 56 ...
Eligibility Criteria
Inclusion
- Histologically confirmed chordoma
- Considered to have high risk disease
- Measurable disease
- Life expectancy \> 3 months
- Adequate organ function
- Able to swallow oral capsules
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01407198
Start Date
August 1 2011
End Date
June 1 2025
Last Update
December 19 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114