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

Phase 2

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: CP-751,871; Drug: Docetaxel

• Registration Number: NCT00678626
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-15
• Study Start: 2009-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	CP-751,871	combination of CP-751,871 + docetaxel administered
Arm B	Docetaxel	chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	3 years

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire	3 years
Overall Response	3 years
Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)	3 years
Overall Survival	3 years
Optional tissue markers of the IGF-1R pathway from tumor tissue obtained	3 years
Safety and tolerability	3 years
Pharmacokinetics of CP-751,871	3 years