Clinical trial · Interventional
Nilotinib With Radiation for High Risk Chordoma
Phase I Study of Nilotinib Given With Radiation For Patients With High Risk Chordoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chordoma | Chordoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nilotinib | Drug | Nilotinib | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nilotinib/XRT
- description
- Nilotinib is administered 400mg PO BID for 2 weeks and then administered concurrently with daily radiation therapy until completion of radiation therapy. Participants can then undergo surgery if clinically possible. After either surgery or definitive radiation, participants have the option to continue on nilotinib therapy.
- interventionNames
- Drug: Nilotinib
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- To determine the dose limiting toxicities (DLTs) for participants when treated above the maximum tolerated dose (MTD).
- timeFrame
- 2 years
- description
- A DLT will be defined as any of the following events occurring during days 1-56 of study according to CTCAE version 4.0. MTD is then determined by identifying a dose cohort demonstrating \> or = 30% rate of DLTs, which are defined as: * Any Grade ≥ 3 nonhematologic toxicity except alopecia, nausea, or vomiting not otherwise controlled by maximual supportive care. * Grade 4 neutropenia (ANC \< 500/µL) lasting \> 5 days, Grade 3 thrombocytopenia lasting \> 7 days, or Grade 4 thrombocytopenia * Failure to resume treatment delays within a defined period of time.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available