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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00106145 | A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014) | PHASE1 | COMPLETED | 103 | — | — | Apr 1, 2005 | Aug 1, 2011 | Jan 30, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| Part I - Arm 1 | EXPERIMENTAL | - |
| Part II - Arm 1 | EXPERIMENTAL | - |
| Part III - Arm 1 | EXPERIMENTAL | - |
| Part IV - Arm 1 | EXPERIMENTAL | - |
| Part V - Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Comparator: MK0752, Notch Inhibitor | DRUG | Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule. |
| Comparator: MK0752, Notch Inhibitor - 450 mg | DRUG | Dose 450 mg capsules daily for 28 day cycles. |
| Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off | DRUG | Dose escalating in a repeating intermittent dosing schedule of 3 days on and 4 days off at rising dose levels of 450, 600, 800, 1000, 1200, and 1400 mg/day. |
| Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off | DRUG | Dose escalating in a repeating intermittent dosing schedule of 1 day on/6 days off at rising dose levels of 600, 900, 1200, 1500, 1800, 2400, 3200 mg/day once weekly and then increase at 33% increments. |
| Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg | DRUG | Dose 350 mg capsules daily intermittent 3 days on/4 days off dosing. THIS DOSING SCHEDULE IS NO LONGER UNDER INVESTIGATION |
Inclusion Criteria: * Women or men greater than or equal to 18 years of age * ECOG status less than or equal to 2 (a measurement to determine your ability to perform daily activities) * In Parts I, III, and IV, patient must have a histologically confirmed, metastatic or locally advanced solid tumor...