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Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Neoplasms

Intervention: Sunitinib (Sutent) (Drug); Taxotere (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

This study is to evaluate the safety of SU011248 (Sunitinib/Sutent) in combination with docetaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

Clinical Details

Official title: Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Area Under the Plasma Concentration-time Profile From Time Zero (0) to 24 Hours (AUC24): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters

Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters

Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters

Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters

Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters

Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters

Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters

Secondary outcome:

Progression-Free Survival (PFS) Based on Investigator Assessment

Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment

Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment

Duration of Tumor Response Based on Investigator Assessment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Breast cancer with evidence of unresectable, locally recurrent or metastatic disease

- Candidate for treatment with docetaxel

Exclusion Criteria:

- Prior chemotherapy in the advanced disease setting

- Inflammatory breast cancer

- HER2 positive disease

Locations and Contacts

Pfizer Investigational Site, Bruxelles 1000, Belgium

Pfizer Investigational Site, Milano 20133, Italy

Pfizer Investigational Site, Stockholm 171 76, Sweden

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2006
Last updated: November 19, 2009

Page last updated: August 23, 2015

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