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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00291577
Date of registration:	13/02/2006
Prospective Registration:	Yes
Primary sponsor:	Pfizer
Public title:	Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer
Scientific title:	Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer
Date of first enrolment:	July 2006
Target sample size:	22
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00291577
Study type:	Interventional
Study design:
Phase:	Phase 1

Countries of recruitment
Belgium	Italy	Sweden

Contacts

Name:	Pfizer CT.gov Call Center
Address:
Telephone:
Email:
Affiliation:	Pfizer

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: Taxotere

Drug: Sunitinib (Sutent)

Primary Outcome(s)

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

Secondary Outcome(s)

Duration of Tumor Response Based on Investigator Assessment [Time Frame: Start of first confirmed CR or PR to first confirmed progression or death]

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]

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]

Progression-Free Survival (PFS) Based on Investigator Assessment [Time Frame: First dose of study treatment until progressive disease]

Secondary ID(s)

A6181100

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	23/12/2009
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00291577

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