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Trial record 1 of 1 for:    NCT00471159
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A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.

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ClinicalTrials.gov Identifier: NCT00471159
Recruitment Status : Withdrawn
First Posted : May 9, 2007
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 7, 2007
First Posted Date  ICMJE May 9, 2007
Last Update Posted Date May 4, 2015
Study Start Date  ICMJE August 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2007)
  • Progression-free survival
  • Tumor assessment every 6 weeks until disease progression
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2007)
Progression-free survival Tumor assessment every 6 weeks until disease progression
Change History Complete list of historical versions of study NCT00471159 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2007)
  • Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
  • Overall Survival - Patients will be followed for survival
  • Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up
  • Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2007)
  • Overall objective response rate
  • Duration of response
  • Time to tumor progression
  • Tumor assessment every 6 weeks until disease progression
  • Overall survival - Data will be collected until death
  • Overall safety profile
  • Targeted questions to patients throughout study
  • Weekly blood sampling during treatment, every 3 weeks during follow-up
  • Urine sample every 3 weeks during treatment and follow-up
  • Changes in pain symptoms
  • Brief Pain Inventory questionnaire every 3 weeks during chemotherapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Docetaxel Or Docetaxel Plus PF-3512676 To Treat Patients With Advanced Breast Cancer.
Official Title  ICMJE A Randomized Phase 2 Clinical Trial Of Docetaxel With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Breast Cancer
Brief Summary To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: docetaxel
  • Drug: PF-3512676
Study Arms  ICMJE Not Provided
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 30, 2015)
0
Original Enrollment  ICMJE
 (submitted: May 7, 2007)
100
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patients with confirmed advanced breast cancer.
  • Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.
  • Patients with adequate general well-being, kidney and liver function.

Exclusion Criteria:

  • Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.
  • Patients who have had prior chemotherapy for advanced breast cancer.
  • Patients of child-bearing potential who are unwilling to use contraception.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00471159
Other Study ID Numbers  ICMJE A8501007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2015

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