Clinical trial NCT00291577: Study Of SU011248 In Combination With Docetaxel In Patients With Metastatic Breast Cancer
Official title: Exploratory Evaluation Of A Sequential Administration Of Docetaxel And SU011248 In Women With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Keywords: advanced
sunitinib (Sutent)
docetaxel
Phase 1B
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-02-14
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
timeFrame: 1, 2, 4, 6, 8, 12, 24 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
timeFrame: 1, 2, 4, 6, 8, 12, 24 hours postdose
measure: 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
timeFrame: 1, 2, 4, 6, 8, 12, 24 hours postdose
measure: Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
timeFrame: 1, 2, 4, 6, 8, 12, 24 hours postdose
measure: Trough Plasma Concentration (Ctrough) at Time Zero (0): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters
timeFrame: 0 hour postdose
measure: Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
measure: Area Under the Plasma Concentration-time Curve From Time Zero (0) to 24 Hours (AUC24): Docetaxel PK Parameters
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
measure: Area Under the Plasma Concentration-time Curve From Time Zero (0) to 48 Hours (AUC48): Docetaxel PK Parameters
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
measure: Area Under the Curve From Time 24 Hours to 48 Hours (AUC24_48) : Docetaxel PK Parameters
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
measure: Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Docetaxel PK Parameters
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
measure: Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose
Secondary outcomes:
measure: Progression-Free Survival (PFS) Based on Investigator Assessment
timeFrame: First dose of study treatment until progressive disease
measure: Number of Subjects With Objective Response of Complete Response or Partial Response Based on Investigator Assessment
timeFrame: First dose of study treatment until at least 4 weeks after confirmed response or partial response
measure: Number of Subjects With Clinical Benefit of Complete Response, Partial Response, or Stable Disease Based on Investigator Assessment
timeFrame: First dose of study treatment until at least 24 weeks on study
measure: Duration of Tumor Response Based on Investigator Assessment
timeFrame: Start of first confirmed CR or PR to first confirmed progression or death
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: