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NCT01407198 · ClinicalTrials.gov registry record · Phase 1
Nilotinib With Radiation for High Risk Chordoma
A Phase 1 study of Chordoma, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT01407198: Completed Phase 1 study of Chordoma, sponsored by Massachusetts General Hospital.
NCT01407198 is a Phase 1 study of Chordoma that has completed, run by Massachusetts General Hospital. The registered enrollment target is 23 participants, below the 86-participant average among 15 other Chordoma trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01407198, a Phase 1 study of Chordoma, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 * Fa
Conditions Studied
Interventions
- RADIATION Radiation therapy
- DRUG Nilotinib
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-08 |
| Est. Completion | 2025-06 |
| Phase | Phase 1 |
What the finished NCT01407198 record still lists
NCT01407198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 86-participant average among 15 other Chordoma trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Chordoma appearing as the primary indexed condition, and to 2 interventions - of which Radiation therapy is the first listed.
NCT01407198 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01407198 about?
NCT01407198 is a clinical study titled "Nilotinib With Radiation for High Risk Chordoma". 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 nilotin...
What is the current status of trial NCT01407198?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2011-08. Estimated completion is 2025-06.
What conditions does trial NCT01407198 study?
This clinical trial studies the following conditions: Chordoma.
What interventions are being tested in trial NCT01407198?
The interventions under investigation include: Radiation therapy (RADIATION), Nilotinib (DRUG).
Who is sponsoring clinical trial NCT01407198?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01407198 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chordoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01407198's enrollment target sits among peer trials
23 12th of 15 higher than 4 of 15 other Chordoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chordoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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