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

NCT00106145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2015-01-30

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2011-08-31
Completion
2011-08-31

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Entities

Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00106145 on ClinicalTrials.gov