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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

Must not have

Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery

Another primary malignant disease which requires systemic treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My cancer is confirmed to be chordoma through tissue examination.

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I can swallow pills.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery in the last 4 weeks or I've recovered from it.

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I have another cancer that needs treatment through the bloodstream.

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I have liver or severe kidney problems not caused by my cancer.

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I have a history of serious bleeding problems not related to cancer.

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I need to take coumadin for blood thinning.

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I have been treated with a tyrosine kinase inhibitor before.

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My heart does not function properly.

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I am currently on strong medication that affects liver enzyme levels.

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I have a stomach or intestine problem that affects how I absorb medicine.

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I have a pancreatic disease.

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I have had radiotherapy for chordoma cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the dose limiting toxicities (DLTs) for participants when treated above the maximum tolerated dose (MTD).

Secondary study objectives

Number of Participants with Adverse Events

PDGFR signaling

Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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