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

Phase 1

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: Sunitinib (Sutent); Drug: Taxotere

• Registration Number: NCT00291577
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Study First Posted: 2006-02-14
• Study Start: 2006-07
• Primary Completion: 2008-10
• Study Completion: 2009-02
• Results First Submitted: 2009-10-01
• Status Verified: 2009-11
• Results First Submitted QC: 2009-11-19
• Last Update Submitted: 2009-11-19
• Results First Posted: 2009-12-23
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
• Candidate for treatment with docetaxel

Read More

Exclusion Criteria

• Prior chemotherapy in the advanced disease setting
• Inflammatory breast cancer
• HER2 positive disease

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Sunitinib (Sutent)	-
1	Taxotere	-

Primary Outcome Measures

Name	Time	Method
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	Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.
Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters	1, 2, 4, 6, 8, 12, 24 hours postdose	Mean Cmax = maximum plasma concentration for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured as nanograms per milliliter (ng/mL); collected C1D2, C2D3. Paired observation; Cmax dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
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	Mean AUC24 = area under plasma concentration-time profile from time 0 to 24 hours for SU011248, SU012662, and combined SU011248 and SU012662 (total drug) measured in nanograms times hour per milliliter (ng\*hr/mL); collected C1D2, C2D3. Paired observation; AUC24 dose corrected C2D3 (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
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	Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D2, C2D3. Data did not allow calculation of AUClast; not summarized; AUC summarized in outcome measure: Area under the plasma concentration-time curve from time zero (0) to 24 hours (AUC24): 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	0 hour postdose	Mean Ctrough=plasma concentration-time profile at time 0 (predose); collected C1D2, C1D15, and C2D1. Calculated by setting concentration values below the limit of quantification to zero.
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	Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.
Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters	0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	Mean Cmax = maximum plasma concentration for Docetaxel; collected C1D1, C2D1. Paired observation; Cmax dose corrected (dose correction if predose concentrations of SU011248 or SU012662 were \> 5% of Cmax).
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	Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.
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	Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.
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	Mean AUC24_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.
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	Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.
Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters	0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose	Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) Based on Investigator Assessment	First dose of study treatment until progressive disease	Median time (50 percent \[%\]) from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first; based on Investigator assessment. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7.
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	Number of subjects with objective response based on Investigator assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response.
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	Number of subjects with clinical benefit based on Investigator assessment of confirmed complete response (CR), partial response (PR), or stable disease (SD) according to RECIST for at least 24 weeks on study.
Duration of Tumor Response Based on Investigator Assessment	Start of first confirmed CR or PR to first confirmed progression or death	Median duration (50%) of tumor response based on Investigator assessment for a subgroup of subjects with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for duration of response (DR). DR defined as time from start of first documented objective tumor response (CR or PR) to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Stockholm, Sweden