Neoplasms Clinical Trial
Official title:
An Open-label, Phase I, Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of BAY87-2243 Given Once Daily in Subjects With Advanced Malignancies
This is the first study of this drug in human beings. Every patient will receive the drug,
there is no placebo group. Patients with advanced tumors will be treated. Different groups
of patients will receive different dosages to determine the safety and maximum tolerated
dose (MTD) of BAY87-2243. The study will also assess how the drug is metabolized by the
body, its biologic effects in the body, and changes in tumor size.
BAY87-2243 will be given as a tablet which dissolves in the gut. Based on findings from this
study it may be later given as a tablet which dissolves in the stomach.
BAY87-2243 will be given per mouth, once a day, every day. Treatment will stop if the tumor
continues to grow, if side effects occur which the patient can not tolerate or if the
patients decides to exit treatment.
The study will be conducted in 3 - 4 centers in 3 countries (Norway, United Kingdom and
Germany). The study will have a part where doses are escalated in different groups of
patients. Each dose level will be evaluated in a new group of 3 - 6 subjects. This will be
followed by an extension part where patients are treated at the highest tolerable dose in
groups of up to 25 patients. The extension part will be described in an amendment to the
study protocol later. The number of subjects estimated for this study will depend on the
number of groups enrolled. The starting dose will be 5 mg given orally as a tablet
formulation.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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