Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01447732 | Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors | PHASE1 | COMPLETED | 71 | — | — | Oct 1, 2011 | Jan 1, 2015 | Apr 29, 2024 | - | — |
The safety of CEP-37250/KHK2804 will be determined by reported adverse events (AEs), changes in the physical examinations, vital laboratory evaluations, and treatment discontinuations due to toxicity.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Dose escalation in subjects with advanced solid tumors with Part 1 which includes intervention of CEP-37250/KHK2804 |
| Part 2 | EXPERIMENTAL | Subjects with colorectal or pancreatic cancer Part 2 which includes intervention of CEP-37250/KHK2804 |
| Name | Type | Description |
|---|---|---|
| CEP-37250/KHK2804 | DRUG | Part 1 is based on the CEP-37250/KHK2804 tolerability and safety data from three subjects enrolled in a cohort, enrollment at the next dose level or additional subjects into the ongoing cohort will occur based upon the number subjects with DLT at a given dose level. Dose depends on subject's body weight. Part 1 includes intervention of CEP-37250/KHK2804. Part 2 will receive CEP-37250/KHK2804 at a dose to be determined following completion of Part 1. |
Inclusion Criteria: * Adequate hepatic, renal, and hematologic function; * Life expectancy \> 3 months; * Part 1 and 2: The subject has histopathologically or cytologically documented, measurable, unresectable, locally advanced primary or recurrent, metastatic solid tumor, locally advanced primary ...