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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02013804 | A Phase 1 Multicenter Open-label Study to Evaluate the Safety Tolerability and PK of MEDI0680 (AMP-514) in Subjects With Advanced Malignancies | PHASE1 | COMPLETED | 58 | — | — | Dec 19, 2013 | May 18, 2017 | Oct 6, 2017 | 6 | United States |
The primary objectives are to assess the safety and tolerability of multiple doses of MEDI0680 (AMP-514) and define the maximum tolerated dose (MTD) or highest protocol-defined dose of MEDI0680 (AMP-514) in the absence of exceeding the MTD.
| Arm | Type | Description |
|---|---|---|
| Dose arms | EXPERIMENTAL | Dose Escalation |
| Name | Type | Description |
|---|---|---|
| MEDI0680 (AMP-514) | DRUG | Study has planned dose escalation cohorts |
Inclusion Criteria: 1. At least 18 years of age at time of study entry 2. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act \[HIPAA\] in the USA) obtained from the subject/legal representative prior to performing any protocol-re...