A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00106145|
Recruitment Status : Completed
First Posted : March 22, 2005
Last Update Posted : January 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer Other Solid Tumors||Drug: Comparator: MK0752, Notch Inhibitor Drug: Comparator: MK0752, Notch Inhibitor - 450 mg Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off Drug: Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
|Experimental: Part I - Arm 1||
Drug: Comparator: MK0752, Notch Inhibitor
Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule.
|Experimental: Part II - Arm 1||
Drug: Comparator: MK0752, Notch Inhibitor - 450 mg
Dose 450 mg capsules daily for 28 day cycles.
|Experimental: Part III - Arm 1||
Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off
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.
|Experimental: Part IV - Arm 1||
Drug: Comparator: MK0752, Notch Inhibitor - 1 day on, 6 off
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.
|Experimental: Part V - Arm 1||
Drug: Comparator: MK0752, Notch Inhibitor - 3 days on, 4 off 350 mg
Dose 350 mg capsules daily intermittent 3 days on/4 days off dosing. THIS DOSING SCHEDULE IS NO LONGER UNDER INVESTIGATION
- Safety and tolerability; MTD will be established [ Time Frame: Day 1 to Day 28 ]
- Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations [ Time Frame: radigraphic evaluation = every 56 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106145
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|