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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00471159
Other study ID # A8501007
Secondary ID
Status Withdrawn
Phase Phase 2
First received May 7, 2007
Last updated April 30, 2015
Start date August 2007

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

To assess the efficacy and safety of PF-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female patients with confirmed advanced breast cancer.

- Patients with HER-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen.

- Patients with adequate general well-being, kidney and liver function.

Exclusion Criteria:

- Patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study.

- Patients who have had prior chemotherapy for advanced breast cancer.

- Patients of child-bearing potential who are unwilling to use contraception.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
docetaxel

PF-3512676


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
Primary Tumor assessment every 6 weeks until disease progression
Secondary Overall objective response rate, duration of response, time to tumor progression - tumor assessment every 6 weeks until disease progression
Secondary Overall Survival - Patients will be followed for survival
Secondary Overall safety profile -Targeted questions to patients throughout study, Weekly blood sampling during treatment, every 3 weeks during follow-up, Urine sample every 3 weeks during treatment and follow-up
Secondary Changes in pain symptoms -Brief Pain Inventory questionnaire every 3 weeks during chemotherapy
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