Advance solid tumors
Conditions
Brief summary
Number of participants with adverse events (AEs), Number of participants with serious adverse events (SAEs), Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera, Number of participants with AEs leading to discontinuation, Number of participants with AEs leading to death, Number of DLTs that occur during the DLT evaluation period
Detailed description
Maximum observed serum concentration (Cmax), Time of maximum observed concentration (Tmax), Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)), Area under the serum concentration-time curve within a dosing interval (AUC(TAU)), Objective response rate (ORR), Best Overall Response (BOR)
Interventions
Sponsors
Bristol-Myers Squibb Services Unlimited Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs), Number of participants with serious adverse events (SAEs), Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera, Number of participants with AEs leading to discontinuation, Number of participants with AEs leading to death, Number of DLTs that occur during the DLT evaluation period | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax), Time of maximum observed concentration (Tmax), Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)), Area under the serum concentration-time curve within a dosing interval (AUC(TAU)), Objective response rate (ORR), Best Overall Response (BOR) | — |
Countries
France, Italy, Netherlands, Spain
Outcome results
None listed