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Trial record 1 of 1 for:    NCT00678626
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Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00678626
Recruitment Status : Withdrawn
First Posted : May 15, 2008
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE May 12, 2008
First Posted Date  ICMJE May 15, 2008
Last Update Posted Date May 4, 2015
Study Start Date  ICMJE April 2009
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2008)
Progression Free Survival [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00678626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2008)
  • Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies) [ Time Frame: 3 years ]
  • Overall Response [ Time Frame: 3 years ]
  • Overall Survival [ Time Frame: 3 years ]
  • Safety and tolerability [ Time Frame: 3 years ]
  • Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire [ Time Frame: 3 years ]
  • Pharmacokinetics of CP-751,871 [ Time Frame: 3 years ]
  • Optional tissue markers of the IGF-1R pathway from tumor tissue obtained [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2008)
  • Pharmacokinetics of CP-751,871 [ Time Frame: 3 years ]
  • Optional tissue markers of the IGF-1R pathway from tumor tissue obtained [ Time Frame: 3 years ]
  • Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire [ Time Frame: 3 years ]
  • Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies) [ Time Frame: 3 years ]
  • Overall Response [ Time Frame: 3 years ]
  • Overall Survival [ Time Frame: 3 years ]
  • Safety and tolerability [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer
Official Title  ICMJE A Randomized Phase 2, Open-Label Study Of CP-751,871 In Combination With Docetaxel And Docetaxel Alone As A First Line Treatment Of Patients With Advanced Breast Cancer
Brief Summary This study will assess the effectiveness of CP- 751,871 when given in combination with docetaxel to women with the first occurrence of advanced breast cancer disease. The effectiveness will be measured by progression-free survival duration. Patients will be followed for 2 years from the date of randomization.
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 Cancer
Intervention  ICMJE
  • Drug: CP-751,871
    Docetaxel administered every 3 weeks. CP-751,871 administered every 3 weeks. CP-751,871 administration (20 mg/kg IV) will continue after the docetaxel is stopped.
  • Drug: Docetaxel
    Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.
Study Arms  ICMJE
  • Experimental: Arm A
    combination of CP-751,871 + docetaxel administered
    Intervention: Drug: CP-751,871
  • Active Comparator: Arm B
    chemotherapy
    Intervention: 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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 30, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2008)
200
Estimated Study Completion Date  ICMJE September 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically or cytologically confirmed diagnosis with evidence of either metastatic disease (Stage IV) of locally recurrent disease not amenable to curative resection or radiation therapy (Stage IIIB).
  • Her-2negative breast cancer or unknown Her-2 status.
  • at least 1 measurable lesion as defined by RECIST.
  • ECOG status 0-1
  • adequate bone marrow, hepatic and renal function.
  • left ventricular ejection fraction of greater than or equal to 50%.
  • willingness to discontinue hormonal therapy.

Exclusion Criteria:

  • any previous chemotherapy for advanced disease.
  • prior exposure to taxanes as (neo) adjuvant treatment less than 12 months prior to randomization.
  • symptomatic brain metastases.
  • prior anti-IGF-1R based investigational therapy.
  • peripheral neuropathy greater than grade 2.
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 NCT00678626
Other Study ID Numbers  ICMJE A4021008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
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