NCT00291577

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2006

Typical duration for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 23, 2009

Completed
Last Updated

December 23, 2009

Status Verified

November 1, 2009

Enrollment Period

2.3 years

First QC Date

February 13, 2006

Results QC Date

October 1, 2009

Last Update Submit

November 19, 2009

Conditions

Breast Neoplasms

Keywords

advancedsunitinib (Sutent)docetaxelPhase 1B

Outcome Measures

Primary Outcomes (12)

  • Time to Reach Maximum Plasma Concentration (Tmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

    Median Tmax = time for maximum plasma concentration (Cmax) for SU011248, SU012662, and combined SU011248 and SU012662 (total drug); collected C1D2, C2D3. Paired observation.

    1, 2, 4, 6, 8, 12, 24 hours postdose

  • Maximum Observed Plasma Concentration (Cmax): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

    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).

    1, 2, 4, 6, 8, 12, 24 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

    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).

    1, 2, 4, 6, 8, 12, 24 hours postdose

  • Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast): Sunitinib (SU011248), Sunitinib Metabolite (SU012662), and Total Drug PK Parameters

    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.

    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

    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.

    0 hour postdose

  • Time to Reach Maximum Plasma Concentration (Tmax): Docetaxel PK Parameters

    Median Tmax = time to maximum plasma concentration (Cmax) for Docetaxel; collected C1D1, C2D1. Paired observation.

    0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

  • Maximum Observed Plasma Concentration (Cmax): Docetaxel PK Parameters

    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).

    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 24 Hours (AUC24): Docetaxel PK Parameters

    Mean AUC24 = area under the plasma concentration-time profile from time 0 to 24 hours; collected C1D1, C2D1. Paired observation.

    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

    Mean AUC48 = area under the plasma concentration-time profile from time 0 to 48 hours; collected C1D1, C2D1. Paired observation.

    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

    Mean AUC24\_48 = area under the plasma concentration-time profile from 24 to 48 hours; collected C1D1, C2D1. Paired observation.

    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

    Mean AUClast = area under the plasma concentration-time profile from time 0 (predose) to the last measurable concentration; collected C1D1, C2D1. Paired observation.

    0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

  • Plasma Elimination Half-life (t1/2): Docetaxel PK Parameters

    Mean Thalf (t1/2) = terminal elimination half life; collected C1D1, C2D1. Paired observation.

    0.5, 1, 1.5, 2, 3, 4, 6, 8, 24, 32, 48 hours postdose

Secondary Outcomes (4)

  • Progression-Free Survival (PFS) Based on Investigator Assessment

    First dose of study treatment until progressive disease

  • 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 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

  • Duration of Tumor Response Based on Investigator Assessment

    Start of first confirmed CR or PR to first confirmed progression or death

Study Arms (1)

1

EXPERIMENTAL
Drug: Sunitinib (Sutent)Drug: Taxotere

Interventions

Sunitinib (Sutent)DRUG

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

Also known as: Sutent
1
TaxotereDRUG

Taxotere 75 mg/m2 iv, once every 3 weeks

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pfizer Investigational Site

Brussels, 1000, Belgium

Location

Pfizer Investigational Site

Milan, 20133, Italy

Location

Pfizer Investigational Site

Stockholm, 171 76, Sweden

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

SunitinibDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 14, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2008

Study Completion

February 1, 2009

Last Updated

December 23, 2009

Results First Posted

December 23, 2009

Record last verified: 2009-11

Locations

SE(1)BE(1)IT(1)