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

This study has been terminated.
(The study was terminated on June 24th, 2015 due to change in strategy of PF-03084014 development. There were no safety/efficacy concerns behind the decision.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01876251
First Posted: June 12, 2013
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Breast Cancer Metastatic Drug: PF-03084014 Drug: Docetaxel Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: 21 days ]
    First cycle dose limiting toxicity

  • Progression-Free Survival (PFS) [ Time Frame: 6 months ]
    The period from study entry until disease progression, death or date of last contact.


Secondary Outcome Measures:
  • QTc Interval [ Time Frame: 2 years ]
    QTc duration

  • Changes in gene expression levels (PD biomarkers) [ Time Frame: 2 years ]
    Change in gene expression levels

  • Changes in analyte levels from baseline to post-treatment (PD biomarkers) [ Time Frame: 2 years ]
    Change in analyte expression

  • Percentage of Participants With Objective Response [ Time Frame: 2 years ]
  • Duration of Response (DR) [ Time Frame: 2 years ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 2 years ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 2 years ]

Enrollment: 30
Study Start Date: November 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: PF-03084014
Tablet, 10 mg, twice a day
Drug: PF-03084014
Tablet, 50 mg, twice a day
Drug: PF-03084014
Tablet, 100 mg, twice a day
Drug: Docetaxel
Solution for IV infusion 75 mg/m^2, every 3 weeks
Other Name: Taxotere
Drug: Docetaxel
Solution for IV infusion 100 mg/m^2, every 3 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876251


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
University of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States, 35249
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, California
Stanford Cancer Institute
Stanford, California, United States, 94305
Stanford Hospital & Clinics-DRUG SHIPMENT ADDRESS only
Stanford, California, United States, 94305
Stanford Hospital & Clinics
Stanford, California, United States, 94305
Stanford Women's Cancer Center
Stanford, California, United States, 94305
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute (KCI)
Detroit, Michigan, United States, 48201
United States, North Carolina
UNC Cancer Hospital Infusion Pharmacy
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7600
Belgium
Jules Bordet Institut
Bruxelles, Belgium, 1000
Italy
Instituto Europeo di Oncologia
Milano, Italy, 20141
Spain
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01876251     History of Changes
Other Study ID Numbers: A8641016
2013-000659-41 ( EudraCT Number )
First Submitted: June 10, 2013
First Posted: June 12, 2013
Last Update Posted: March 28, 2017
Last Verified: January 2016

Keywords provided by Pfizer:
Breast cancer metastatic
docetaxel
PF-03084014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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