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

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NCT01876251

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer Metastatic
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with a gamma secretase inhibitors or other Notch signaling inhibitors.

NCT01876251
Pfizer
Terminated
A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer

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A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer
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.
Not Provided
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer Metastatic
  • 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
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
Interventions:
  • Drug: PF-03084014
  • Drug: PF-03084014
  • Drug: PF-03084014
  • Drug: Docetaxel
  • Drug: Docetaxel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
December 2015
December 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Italy,   Spain,   United States
 
 
NCT01876251
A8641016
2013-000659-41 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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