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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This study has been withdrawn prior to enrollment.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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00678626
First received: May 12, 2008
Last updated: December 3, 2008
Last verified: November 2008
History of Changes

May 12, 2008
December 3, 2008
April 2009
September 2011   (final data collection date for primary outcome measure)
Progression Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Overall Response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics of CP-751,871 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Optional tissue markers of the IGF-1R pathway from tumor tissue obtained [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
200
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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00678626
A4021008
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2008

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