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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291577
• Other study ID #: A6181100
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2006
• Last updated: November 19, 2009
• Start date: July 2006
• Est. completion date: February 2009

Study information

• Verified date: November 2009
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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
• Taxotere
Taxotere 75 mg/m2 iv, once every 3 weeks

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Italy	Pfizer Investigational Site	Milano
Sweden	Pfizer Investigational Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters		1, 2, 4, 6, 8, 12, 24 hours postdose	No
Primary	Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters		1, 2, 4, 6, 8, 12, 24 hours postdose	No
Primary	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		1, 2, 4, 6, 8, 12, 24 hours postdose	No
Primary	Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters		1, 2, 4, 6, 8, 12, 24 hours postdose	No
Primary	Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters		0 hour postdose	No
Primary	Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters		0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	No
Primary	Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters		0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	No
Primary	Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters		0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	No
Primary	Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters		0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	No
Primary	Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters		0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	No
Primary	Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters		0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	No
Primary	Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters		0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	No
Secondary	Progression-Free Survival (PFS) Based on Investigator Assessment		First dose of study treatment until progressive disease	No
Secondary	Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment		First dose of study treatment until at least 4 weeks after confirmed response or partial response	No
Secondary	Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment		First dose of study treatment until at least 24 weeks on study	No
Secondary	Duration of Tumor Response Based on Investigator Assessment		Start of first confirmed CR or PR to first confirmed progression or death	No

External Links

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