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A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer (0752-014) | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT00106145•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Women or men greater than or equal to 18 years of age
•ECOG status less than or equal to 2 (a measurement to determine your ability to perform daily activities)
•In Parts I, III, and IV, patient must have a histologically confirmed, metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. There is no limit on the number of prior treatment regimens
•In Part II, only breast cancer patients are eligible
•In Part V, only patients with Numb negative breast cancer (i.e., tumor shows Numb immunoreactivity in less than 10% of the neoplastic cells assessed) are eligible
•Patient has recovered from and is at least 2 weeks from previous antineoplastic therapy, including chemotherapy, biological therapy (including Herceptin), hormonal therapy, radiotherapy, or surgery

Exclusion Criteria

•Patient has had an investigational treatment in the preceding 21 days
•Uncontrolled congestive heart failure or myocardial infarction (heart attack) within 3 months of study start
•History of hepatitis B or C or HIV
•Patient has the presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with CNS metastases who have completed a course of radiotherapy and are clinically stable in the judgment of the investigator are eligible
•Patients with "currently active" second malignancy, other than non-melanoma skin cancer, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for prior malignancy and are considered by their physician to be at \<30% risk of relapse

Key Dates

Start Date

April 1, 2005

Primary Completion Date

August 1, 2011

Completion Date

August 1, 2011

Last Updated

January 30, 2015

Enrollment

103

ACTUAL participants

Conditions

Advanced Breast CancerOther Solid Tumors

Interventions

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

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

View study

RECRUITINGPHASE2

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

NCT06649331

Advanced Breast CancerMetastatic Breast Cancer+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

Phase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole

Optimal Methods to Characterize ADC Resistance in Solid Tumors and Identify Clinically Useful Biomarkers