Status:
COMPLETED
Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 follo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged ≥ 18 years
- Patients with histologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available.
- WHO performance status ≤ 2
- All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have been resolved
- Written informed consent to participate in the study
- Exclusion criteria:
- Primary Brain Tumors or symptomatic leptomeningeal metastases
- Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
- Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection Pregnant or lactating women (all women of childbearing potential must have a negative pregnancy test (\> 5 mIU/ml) before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients must use adequate contraceptive protection
- Centrally located or squamous cell carcinoma of the lung
- Proteinuria \> 1+ on dipstick testing
- History of gastrointestinal malabsorption Surgery involving intestinal anastomosis within four weeks of study start.
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00669097
Start Date
April 1 2008
Last Update
December 21 2020
Active Locations (1)
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1
Novartis Investigative Site
Amsterdam, Netherlands