Clinical Study to Evaluate the Maximum Tolerated Dose of BAY87-2243 in Patients 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Frequency of adverse events [ Time Frame: Up to 3 years or longer if indicated ] [ Designated as safety issue: Yes ]
- Maximum tolerated dose, measured by adverse event profile [ Time Frame: Up to 3 years or longer if indicated ] [ Designated as safety issue: Yes ]
- Plasma concentrations of BAY87-2243, measured by Cmax, tmax, AUC(0-tn), AUC and half-life [ Time Frame: Up to 3 years or longer if indicated ] [ Designated as safety issue: Yes ]
- Biomarkers evaluation (analysis of carbonic anhydrase 9 and VEGF in plasma) [ Time Frame: Up to 3 years or longer if indicated ] [ Designated as safety issue: Yes ]
- Tumor response evaluation based on RECIST 1.1 every 2 cycles [ Time Frame: Up to 3 years or longer if indicated ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2011|
|Study Completion Date:||July 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Oral administration once daily in a continuous schedule. Starting dose will be 5 mg and dose will be escalated dependent on any dose limiting toxicities.
|Freiburg, Baden-Württemberg, Germany, 79106|
|Oslo, Norway, 0424|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Study Director:||Bayer Study Director||Bayer|