A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer

NCT ID: NCT01876251

Last Updated: 2019-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-04

Study Completion Date

2015-12-24

Brief Summary

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This study is aimed to determine the tolerability of the PF-03084014 plus docetaxel combination in patients with advanced breast cancer. Preliminary information about the efficacy of the combination will also be collected.

Detailed Description

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Conditions

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Breast Cancer Metastatic

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-03084014 plus docetaxel

PF 03084014 will be administered orally, continuously, twice daily at doses from 80 to 150 mg in combination with docetaxel given every 3 weeks at doses from 75 to 100 mg/m\^2

Group Type EXPERIMENTAL

PF-03084014

Intervention Type DRUG

Tablet, 10 mg, twice a day

PF-03084014

Intervention Type DRUG

Tablet, 50 mg, twice a day

PF-03084014

Intervention Type DRUG

Tablet, 100 mg, twice a day

Docetaxel

Intervention Type DRUG

Solution for IV infusion 75 mg/m\^2, every 3 weeks

Docetaxel

Intervention Type DRUG

Solution for IV infusion 100 mg/m\^2, every 3 weeks

Interventions

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PF-03084014

Tablet, 10 mg, twice a day

Intervention Type DRUG

PF-03084014

Tablet, 50 mg, twice a day

Intervention Type DRUG

PF-03084014

Tablet, 100 mg, twice a day

Intervention Type DRUG

Docetaxel

Solution for IV infusion 75 mg/m\^2, every 3 weeks

Intervention Type DRUG

Docetaxel

Solution for IV infusion 100 mg/m\^2, every 3 weeks

Intervention Type DRUG

Other Intervention Names

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Taxotere

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of breast cancer with evidence of a) metastatic or b) locally recurrent/advanced disease.

Exclusion Criteria

* Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham, IDS Pharmacy

Birmingham, Alabama, United States

Site Status

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Stanford Cancer Institute

Stanford, California, United States

Site Status

Stanford Hospital & Clinics-DRUG SHIPMENT ADDRESS only

Stanford, California, United States

Site Status

Stanford Hospital & Clinics

Stanford, California, United States

Site Status

Stanford Women's Cancer Center

Stanford, California, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Karmanos Cancer Institute (KCI)

Detroit, Michigan, United States

Site Status

UNC Cancer Hospital Infusion Pharmacy

Chapel Hill, North Carolina, United States

Site Status

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Jules Bordet Institut

Brussels, , Belgium

Site Status

Grand Hopital de Charleroi

Charleroi, , Belgium

Site Status

Instituto Europeo di Oncologia

Milan, , Italy

Site Status

Instituto Catalan de Oncologia de L'Hospitalet de Llobregat(ICO)

Barcelona, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Countries

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United States Belgium Italy Spain

Related Links

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Other Identifiers

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2013-000659-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A8641016

Identifier Type: -

Identifier Source: org_study_id

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