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

Pfizer0 sitesApril 2009

ConditionsBreast Cancer

InterventionsCP-751,871 Docetaxel

DrugsCP-751,871 Docetaxel

Overview

Phase: Phase 2
Intervention: CP-751,871
Conditions: Breast Cancer
Sponsor: Pfizer
Primary Endpoint: Progression Free Survival
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

September 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Pfizer

Eligibility Criteria

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.

Arms & Interventions

Arm A

combination of CP-751,871 + docetaxel administered

Intervention: CP-751,871

Arm B

chemotherapy

Intervention: Docetaxel

Outcomes

Primary Outcomes

Progression Free Survival

Time Frame: 3 years

Secondary Outcomes

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