NCT00106145

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

A Phase I Study of MK0752, a Notch Inhibitor, in Patients With Metastatic or Locally Advanced Breast Cancer and Other Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Breast Cancer
• Other Solid Tumors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-04-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2005-03-22
• Last updated: 2015-01-30