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

January 29, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability; MTD will be established
Time Frame: Day 1 to Day 28
Day 1 to Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall tumor/disease response will be evaluated using RECIST criteria, radiographic and clinical evaluations
Time Frame: radigraphic evaluation = every 56 days
radigraphic evaluation = every 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

March 21, 2005

First Submitted That Met QC Criteria

March 21, 2005

First Posted (ESTIMATE)

March 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0752-014
  • 2005_008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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