An Open-Label, Non-Randomized, Single-Center, Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion (ADME) of TKI258 After a Single Oral Administration of TKI258 500mg and to Assess the Preliminary Safety of TK258 400mg Once Daily in Patients With Advanced Solid Malignancies
Inclusion Criteria
Inclusion criteria:
1. Aged ≥ 18 years
2. Patients with histologically confirmed solid tumor or lymphoma who are
resistant/refractory to approved therapies or for whom no appropriate therapies are
available.
3. WHO performance status ≤ 2
4. 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
5. Written informed consent to participate in the study
Exclusion criteria:
1. Primary Brain Tumors or symptomatic leptomeningeal metastases
2. Clinically significant cardiac impairment or unstable ischemic heart disease
including a myocardial infarction within six months of study start
3. 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
4. Centrally located or squamous cell carcinoma of the lung
5. Proteinuria > 1+ on dipstick testing
6. History of gastrointestinal malabsorption Surgery involving intestinal anastomosis
within four weeks of study start.
Other protocol-defined inclusion/exclusion criteria may apply.