Status:
COMPLETED
Safety of TKI258 in Advanced/Metastatic Melanoma Subjects
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is an open-label, dose-escalating study to delineate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TKI258. Pharmacokinetics and pharmacodynamics will be performed on all s...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of locally advanced or metastatic melanoma (American Joint Committee on Cancer \[AJCC\] stage IIIB, IIIC or IV) that is refractory to standard therapy or for which no curative standard therapy exists.
- Measurable disease
- Must be eighteen years of age or older
- Must meet baseline laboratory requirements
- ECOG performance status 0 or 1
- Adults of reproductive potential must agree to use effective contraception or be sterile
Exclusion
- Concurrent therapy with any other investigational agent
- Uncontrolled central nervous system metastases
- Impaired cardiac function or clinically significant cardiac disease
- Received
- chemotherapy, targeted therapy or monoclonal antibody therapy ≤4 weeks
- biological therapy or immunotherapy (therapeutic or diagnostic) ≤2 weeks
- an investigational agent (therapeutic or diagnostic) ≤4 weeks prior to starting study drug or has not recovered from side effects of such therapy
- Received any hematopoietic colony-stimulating factor (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin is allowed.
- Has undergone major surgery ≤ 2 weeks prior to starting study drug or has not recovered from side effects of such surgery.
- Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea, diarrhea, vomiting
- Pregnant or breast feeding women
- History of another primary malignancy that is currently clinically significant or currently requires active intervention.
- Chronic anticoagulation therapy with full strength aspirin, Coumadin, or heparin.
- History of thromboembolic or cerebrovascular events within the last 12 months.
- History of rectal bleeding, bloody vomit, or spitting up blood within the last 3 months.
- Known diagnosis of HIV infection (HIV testing is not mandatory)
- Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's wort and quinidine is prohibited.
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the patient inappropriate for this study
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00303251
Start Date
April 1 2006
Last Update
March 11 2021
Active Locations (3)
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1
James Graham Brown Cancer Center
Louisville, Kentucky, United States, 40202
2
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
3
MD Anderson Cancer
Houston, Texas, United States, 77030