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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01876251
First received: June 10, 2013
Last updated: September 8, 2014
Last verified: September 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    First cycle dose limiting toxicity

  • Progression-Free Survival (PFS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The period from study entry until disease progression, death or date of last contact.


Secondary Outcome Measures:
  • QTc Interval [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    QTc duration

  • Changes in gene expression levels (PD biomarkers) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in gene expression levels

  • Changes in analyte levels from baseline to post-treatment (PD biomarkers) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in analyte expression

  • Percentage of Participants With Objective Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Duration of Response (DR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876251

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, California
Pfizer Investigational Site Not yet recruiting
Stanford, California, United States, 94305
United States, Michigan
Pfizer Investigational Site Recruiting
Detroit, Michigan, United States, 48201
United States, North Carolina
Pfizer Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Pfizer Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27514
Belgium
Pfizer Investigational Site Recruiting
Bruxelles, Belgium, 1000
Italy
Pfizer Investigational Site Recruiting
Milano, Italy, 20141
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01876251     History of Changes
Other Study ID Numbers: A8641016
Study First Received: June 10, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014