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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_008 |
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An investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and other advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part I - Arm 1 | Experimental |
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| Part II - Arm 1 | Experimental |
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| Part III - Arm 1 | Experimental |
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| Part IV - Arm 1 | Experimental |
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| Part V - Arm 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK0752, Notch Inhibitor | Drug | Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability; MTD will be established | Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations | radigraphic evaluation = every 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22547604 | Result | Krop I, Demuth T, Guthrie T, Wen PY, Mason WP, Chinnaiyan P, Butowski N, Groves MD, Kesari S, Freedman SJ, Blackman S, Watters J, Loboda A, Podtelezhnikov A, Lunceford J, Chen C, Giannotti M, Hing J, Beckman R, Lorusso P. Phase I pharmacologic and pharmacodynamic study of the gamma secretase (Notch) inhibitor MK-0752 in adult patients with advanced solid tumors. J Clin Oncol. 2012 Jul 1;30(19):2307-13. doi: 10.1200/JCO.2011.39.1540. Epub 2012 Apr 30. |
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| Comparator: MK0752, Notch Inhibitor - 450 mg | Drug | Dose 450 mg capsules daily for 28 day cycles. |
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| 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. |
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| 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. |
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| 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 |
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