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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00880568 | Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED) | PHASE1 | COMPLETED | 27 | — | — | Apr 1, 2009 | Jan 1, 2011 | Feb 19, 2015 | - | — |
Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.
This is a measure of the number of participants who experienced any adverse event (AE) while on study.
| Arm | Type | Description |
|---|---|---|
| MK-1496 20 mg (21-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle |
| MK-1496 40 mg (21-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle |
| MK-1496 80 mg (21-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle |
| MK-1496 120 mg (21-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle |
| MK-1496 20 mg (28-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 40 mg (28-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 80 mg (28-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 100 mg (28-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| MK-1496 120 mg (28-Day Cycle) | EXPERIMENTAL | Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle |
| Name | Type | Description |
|---|---|---|
| MK-1496 | DRUG | MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle |
Inclusion Criteria * Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. * Participant must have Performance Status 0 or 1. * Pa...