← Back to Search

Tyrosine Kinase Inhibitor

Nilotinib + Radiation for Chordoma

Phase 1
Waitlist Available
Led By Edwin Choy, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed chordoma
Able to swallow oral capsules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing a drug, nilotinib, to see if it can help shrink tumors when used with radiation therapy. Researchers want to see if it is safe and what the highest dose is that can be given without causing severe side effects.

Who is the study for?
This trial is for individuals with high-risk chordoma, a type of bone cancer. Participants must have a life expectancy over 3 months, be able to swallow capsules, and have measurable disease with proper organ function. It's not open to those who've had certain heart issues, are on strong CYP3A4 inhibitors or anticoagulants like coumadin, have gastrointestinal problems affecting drug absorption, acute pancreatitis, CNS infiltration by cancer cells, another primary cancer needing treatment, recent major surgery without recovery or investigational agent use within the last month.Check my eligibility
What is being tested?
The study tests Nilotinib combined with radiation therapy in treating advanced chordomas. Nilotinib is believed to slow tumor growth by targeting specific genes in the tumor cells. The goal is to find out how safe this combination is and the highest dose of Nilotinib that can be given safely alongside standard radiation treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions from radiation such as skin irritation and fatigue along with possible effects from Nilotinib like nausea, rash, headaches or changes in blood counts due to its action on cellular enzymes involved in tumor growth regulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is confirmed to be chordoma through tissue examination.
Select...
I can swallow pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the dose limiting toxicities (DLTs) for participants when treated above the maximum tolerated dose (MTD).
Secondary outcome measures
Number of Participants with Adverse Events
PDGFR signaling
Survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nilotinib/XRTExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation therapy
2013
Completed Phase 3
~2850
Nilotinib
2005
Completed Phase 4
~2670

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,326 Total Patients Enrolled
3 Trials studying Chordoma
465 Patients Enrolled for Chordoma
Edwin Choy, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
133 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Nilotinib an acceptable therapeutic option with minimal risk?

"There is limited evidence of the safety and efficacy profile for nilotinib, so it was scored a 1 on our team's scale."

Answered by AI

Is the enrollment for this trial open to new participants?

"The clinicaltrials.gov records illustrate that this trial is not currently enrolling any participants; it was initially posted on August 1, 2011 and its information was last updated October 27th 2021. Nevertheless, there are still 62 other trials actively recruiting patients at the moment."

Answered by AI

What other research initiatives have been undertaken with Nilotinib?

"Currently, 35 medical trials are investigating the use of Nilotinib. Of those in operation, 6 are Phase 3 studies. Although a majority of these research sites can be found near Fukuoka city in Japan, there is a global recruitment effort with 1548 centres participating overall."

Answered by AI

Is this an unprecedented clinical investigation?

"To date, 35 ongoing studies on Nilotinib have been conducted across 42 nations and 566 cities. The very first Nilotinib trial was sponsored by Novartis Pharmaceuticals in 2008; the Phase 4 drug approval stage of this investigation involved 34 individuals. Since then, a further 134 trials for this medication have occurred."

Answered by AI

What is the current sample size of this clinical trial?

"At this juncture, this trial is not accepting any new participants. The research was initially shared on August 1st 2011 and the most recent update was October 27th 2021. There are currently 27 clinical trials for chordoma which require patients, as well as 35 separate studies seeking those taking Nilotinib."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I hope thus clinical trial help me.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Nilotinib With Radiation for High Risk Chordoma
Edwin Choy, MD 2011. "Nilotinib With Radiation for High Risk Chordoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01407198.
All > Chordoma
~2 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top