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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02868229 | Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001 | PHASE1 | COMPLETED | 61 | — | — | Sep 12, 2016 | Dec 11, 2018 | Jul 30, 2021 | 12 | United States |
The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity
Change from the baseline in hsCRP values to week 4 are presented.
Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.
| Arm | Type | Description |
|---|---|---|
| COR-001 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| COR-001 | DRUG | - |
| Placebo | OTHER | - |
INCLUSION CRITERIA 1. Age greater than or equal to 18 years at the time of signing of the ICF. 2. The patient agrees to comply with the contraception and reproduction restrictions of the study 3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuou...