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Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678626
First Posted: May 15, 2008
Last Update Posted: May 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
May 12, 2008
May 15, 2008
May 4, 2015
April 2009
September 2011   (Final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT00678626 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Phase 2 Trial Of CP-751,871 And Docetaxel In Advanced Breast Cancer
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • 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.
  • Experimental: Arm A
    combination of CP-751,871 + docetaxel administered
    Intervention: Drug: CP-751,871
  • Active Comparator: Arm B
    chemotherapy
    Intervention: Drug: Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2011
September 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00678626
A4021008
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2015

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