Japanese BAY80-6946 Monotherapy Phase I Study
Ključne besede
Povzetek
Datumi
| Nazadnje preverjeno: | 11/30/2017 |
| Prvič predloženo: | 07/26/2011 |
| Predviden vpis oddan: | 07/26/2011 |
| Prvič objavljeno: | 07/27/2011 |
| Zadnja posodobitev oddana: | 12/12/2017 |
| Zadnja posodobitev objavljena: | 12/13/2017 |
| Dejanski datum začetka študija: | 08/17/2011 |
| Predvideni datum primarnega zaključka: | 03/21/2012 |
| Predvideni datum zaključka študije: | 07/11/2012 |
Stanje ali bolezen
Intervencija / zdravljenje
Drug: Arm 1
Drug: Arm 2
Faza
Skupine rok
| Roka | Intervencija / zdravljenje |
|---|---|
| Experimental: Arm 1 | Drug: Arm 1 0.4mg/ kg, iv, day 1,8 and 15, every 28 days |
| Experimental: Arm 2 | Drug: Arm 2 0.8mg/ kg, iv, day 1,8 and 15, every 28 days |
Merila upravičenosti
| Starost, primerna za študij | 20 Years Za 20 Years |
| Spol, upravičen do študija | All |
| Sprejema zdrave prostovoljce | Da |
| Merila | Inclusion Criteria: - Cancer patients - Japanese patients, who are at least 20 years of age - Histological or cytological documentation of non-hematologic, malignant solid tumours, excluding primary brain or spinal tumours, with no past or current involvement in the central nervous system (CNS) - At least one measurable lesion or evaluable disease according to RECIST (version 1.1) - Eastern Cooperative Oncology performance status (ECOG-PS) of 0 or 1 - Life expectancy of at least 12 weeks - Advanced or refractory solid tumours not amenable to standard therapy, at the first screening examination/visit Exclusion Criteria: - Anticancer chemotherapy or immunotherapy during the study or within 4 weeks of first study treatment. Patients must have recovered from the toxic effects of the previous anti-cancer chemotherapy or immunotherapy by the investigator (with the exception of alopecia). - Radiotherapy to target lesions during study or within 4 weeks of first study treatment - Investigational drug therapy outside of this trial during or within 4 weeks of first study treatment - Current diagnosis of Type I or II diabetes mellitus or fasting blood glucose level >125 mg/dL at screening, and/or HbA1c>/= 6.5% - Past and current histories of cardiac disease congestive heart failure > New York Heart Association (NYHA) Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset of angina within 3 months prior to study entry or unstable angina or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy - Active and clinically serious infections >Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.03) - Uncontrolled hypertension defined as systolic blood pressure >150 mm Hg or diastolic pressure > 90 mm Hg, despite optimal medical management - Patients undergoing renal dialysis - Pregnant or breast feeding women |
Izid
Primarni izidni ukrepi
1. Number of subjects with adverse events [169 days]
2. Maximum drug concentration in plasma after single dose administration (Cmax) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15]
3. Cmax divided by dose (mg) per kg body weight (Cmax,norm) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15]
4. Cmax divided by dose (mg) (Cmax/D) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15]
5. Area under the concentration-time curve time 0 to 8 hours (AUC(0-8)) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day15]
6. Area under the concentration-time curve from time 0 to 25 hours (AUC(0-25)) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15]
7. AUC(0-25) divided by dose (mg) per kg body weight (AUC(0-25)norm) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15]
8. AUC(0-25) divided by dose (mg) (AUC(0-25)/D) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15]
9. AUC from time 0 to last data point (AUC(0-tlast)) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15]
10. Time to maximum drug concentration in plasma (tmax) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15, 0 - 8 hours in Cycle3 Day 15]
Ukrepi sekundarnega rezultata
1. Area under the plasma concentration-time curve of (AUC) of BAY80-6946 [0 - 168 hours in Cycle1 Day1]
2. Half-life associated with terminal slope of drug in plasma (t1/2) [0 - 168 hours in Cycle1 Day1]
3. Mean residence time of drug in plasma (MRT) [0 - 168 hours in Cycle1 Day1]
4. Total body clearance of drug from plasma (CL) [0 - 168 hours in Cycle1 Day1]
5. Volume of drug distribution during terminal phase after single dose administration (Vz) [0 - 168 hours in Cycle1 Day1]
6. Volume of drug distribution during steady state after single dose administration (Vss) [0 - 168 hours in Cycle1 Day1]
7. Accumulation ratio calculated from AUC(0-8) after multiple dosing and AUC(0-8) after single dosing (RAAUC(0-8)) [0 - 8 hours in Cycle3 Day15]
8. Accumulation ratio calculated from AUC(0-25) after multiple dosing and AUC(0-25) after single dosing (RAAUC(0-25)) [0 - 25 hours in Cycle1 Day15]
9. Accumulation ration calculated from Cmax after multiple dosing and Cmax after single dosing (RACmax) [0 - 168 hours in Cycle1 Day1, 0 - 25 hours in Cycle1 Day15]
10. Overall tumor response rate [176 days]
11. Overall disease control rate [176 days]
12. Time to progression of cancer growth [176 days]
13. Progression-free survival time [176 days]
