Phase I Study of Nilotinib Given With Radiation For Patients With High Risk Chordoma
18 Years
N/A
Both
Chordoma
Trial Information
Phase I Study of Nilotinib Given With Radiation For Patients With High Risk Chordoma
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 of the study. If it is determined that the subject's tumor cannot be
removed by surgery, an additional 3 weeks of radiation therapy will be applied after Day 56
of the study.
During study visits subjects will have physical exams, routine blood tests, urine and blood
clotting tests, and EKGs. Subjects will also have tumor assessment by chest CT and MRI or CT
of the tumor at screening, on approximately Day 56 of the study, then every 6 months for one
year and then annually thereafter if ther is no disease progression.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the dose limiting toxicities (DLTs) for participants when treated above the maximum tolerated dose (MTD).
Outcome 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.
Outcome Time Frame:
2 years
Safety Issue:
Yes
Principal Investigator
Edwin Choy, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Food and Drug Administration
Study ID:
11-072
NCT ID:
NCT01407198
Start Date:
August 2011
Completion Date:
August 2014
Related Keywords:
- Chordoma
- High Risk Chordoma
- Chordoma
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
