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

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NCT01876251

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Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
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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.

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Breast Cancer MetastaticA Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
NCT01876251
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Stanford, California
  5. Stanford, California
  6. Stanford, California
  7. Stanford, California
  8. Detroit, Michigan
  9. Detroit, Michigan
  10. Chapel Hill, North Carolina
  11. Chapel Hill, North Carolina
  12. Bruxelles,
  13. Charleroi,
  14. Milano,
  15. Barcelona,
  16. Madrid,
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Evaluating The PF-03084014 In Combination With Docetaxel In Patients With Advanced Breast Cancer
Official Title  ICMJE Phase 1b Study Of Docetaxel + Pf 03084014 In Metastatic Or Locally Recurrent/Advanced Triple Negative Breast Cancer
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer Metastatic
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 20, 2016)		30
Original Estimated Enrollment  ICMJE
 (submitted: June 10, 2013)		60
Actual Study Completion Date  ICMJE December 24, 2015
Actual Primary Completion Date December 24, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01876251
Other Study ID Numbers  ICMJE A8641016
2013-000659-41 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP