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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01284231 | A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas | PHASE1 | COMPLETED | 78 | — | — | Dec 1, 2010 | Jan 1, 2015 | Mar 3, 2015 | 4 | United States |
MTD/OBD will be determined based on Dose Limiting Toxicities that will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle
The number (percentage) of subjects with AEs and SAEs reported through 30 days after the last dose of MEDI 565 will be summarized for all subjects who received at least one dose of study drug (Safety Population).
| Arm | Type | Description |
|---|---|---|
| MEDI-565 - Dose Escalation | EXPERIMENTAL | Up to 15 dose-escalation cohorts will be enrolled |
| MEDI-565 Dose Expansion Arm 1 | EXPERIMENTAL | 20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose |
| MEDI-565 Dose Expansion Arm 2 | EXPERIMENTAL | 20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose |
| MEDI-565 Dose Expansion Arm 3 | EXPERIMENTAL | Subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biological dose |
| Name | Type | Description |
|---|---|---|
| MEDI-565 | DRUG | MEDI-565 will be administered by IV infusion |
Inclusion Criteria: * Age ≥ 18 years of age at the time of screening * Adequate contraception from screening through end of trial * For the dose-escalation phase, subjects with GI adenocarcinomas with no available standard or curative treatments * Adequate hematological function * Adequate organ fu...