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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00678626
• Other study ID #: A4021008
• Status: Withdrawn
• Phase: Phase 2
• First received: May 12, 2008
• Last updated: April 30, 2015
• Start date: April 2009
• Est. completion date: September 2011

Study information

• Verified date: April 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• Docetaxel
Docetaxel only is administered every 3 weeks. After progression, administration with CP-751, 871 (20 mg/kg IV) is permitted.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		3 years	No
Secondary	Biomarkers (IGF-1R positive Circulating Tumor Cells; Anti-Drug Antibodies)		3 years	No
Secondary	Overall Response		3 years	No
Secondary	Overall Survival		3 years	No
Secondary	Safety and tolerability		3 years	No
Secondary	Patient Reported Outcomes using the MDASI (MD Anderson Symptom Inventory) questionnaire		3 years	No
Secondary	Pharmacokinetics of CP-751,871		3 years	No
Secondary	Optional tissue markers of the IGF-1R pathway from tumor tissue obtained		3 years	No

External Links

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