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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00291577
First received: February 13, 2006
Last updated: November 19, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
 Drug: Sunitinib (Sutent)
Drug: Taxotere
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters [ Time Frame: 1, 2, 4, 6, 8, 12, 24 hours postdose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters [ Time Frame: 1, 2, 4, 6, 8, 12, 24 hours postdose ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1, 2, 4, 6, 8, 12, 24 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters [ Time Frame: 1, 2, 4, 6, 8, 12, 24 hours postdose ] [ Designated as safety issue: No ]
  • Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters [ Time Frame: 0 hour postdose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose ] [ Designated as safety issue: No ]
  • Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) Based on Investigator Assessment [ Time Frame: First dose of study treatment until progressive disease ] [ Designated as safety issue: No ]
  • Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment [ Time Frame: First dose of study treatment until at least 4 weeks after confirmed response or partial response ] [ Designated as safety issue: No ]
  • Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment [ Time Frame: First dose of study treatment until at least 24 weeks on study ] [ Designated as safety issue: No ]
  • Duration of Tumor Response Based on Investigator Assessment [ Time Frame: Start of first confirmed CR or PR to first confirmed progression or death ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: July 2006
Study Completion Date: February 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sunitinib (Sutent)
Sunitinib (Sutent) 37.5 mg in schedule 2/1; Sunitinib (Sutent) 37.5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision
Other Name: Sutent
Drug: Taxotere
Taxotere 75 mg/m2 iv, once every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291577

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1000
Italy
Pfizer Investigational Site
Milano, Italy, 20133
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00291577     History of Changes
Other Study ID Numbers: A6181100
Study First Received: February 13, 2006
Results First Received: October 1, 2009
Last Updated: November 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
advanced
sunitinib (Sutent)
docetaxel
Phase 1B

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Docetaxel
Sunitinib
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013