A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014)

PHASE1CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Advanced Breast CancerOther Solid Tumors
Interventions
DRUG

Comparator: MK0752, Notch Inhibitor

Dose escalating beginning with rising dose levels of 300, 450, and 600 mg/day in a continuous dosing schedule.

DRUG

Comparator: MK0752, Notch Inhibitor - 450 mg

Dose 450 mg capsules daily for 28 day cycles.

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.

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.

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

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00106145 - A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014) | Biotech Hunter | Biotech Hunter