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Trial record 1 of 1 for:    NCT00372424
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Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

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ClinicalTrials.gov Identifier: NCT00372424
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : October 30, 2012
Last Update Posted : December 28, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 5, 2006
First Posted Date  ICMJE September 7, 2006
Results First Submitted Date  ICMJE September 28, 2012
Results First Posted Date  ICMJE October 30, 2012
Last Update Posted Date December 28, 2012
Study Start Date  ICMJE December 2006
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: From screening until 28 days post last dose of study drug ]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
Safety profile of the combination SU011248/docetaxel/trastuzumab
Change History Complete list of historical versions of study NCT00372424 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
  • Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344) ]
    Percentage of participants with objective response based 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. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
  • Progression-free Survival (PFS) [ Time Frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344) ]
    Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
  • Duration of Response (DR) [ Time Frame: Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344) ]
    Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
  • Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662) [ Time Frame: Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1 ]
    Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.
  • Maximum Observed Plasma Concentration (Cmax) of Docetaxel [ Time Frame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6 ]
    Concentration values below the lower limit of quantification were taken as zero.
  • Plasma Trough Concentrations (Ctrough) of Trastuzumab [ Time Frame: Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6 ]
    Ctrough = the concentration prior to study medication administration.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2006)
Preliminary activity (disease free survival, response rate, duration of response) of the combination SU011248/docetaxel/trastuzumab.
Current Other Pre-specified Outcome Measures
 (submitted: September 28, 2012)
Maximum Observed Plasma Concentration (Cmax) of Paclitaxel [ Time Frame: End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
Official Title  ICMJE An Explorative Study Of The Tolerability Of SU011248 In Combination With Docetaxel And Trastuzumab As First-Line Treatment In Patients With Breast Cancer Over-Expressing HER-2
Brief Summary This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment in the advanced disease setting.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Herceptin
    Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.
    Other Name: trastuzumab
  • Drug: Sunitinib
    SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.
    Other Name: Sutent
  • Drug: Taxotere
    The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
    Other Name: docetaxel
Study Arms  ICMJE Experimental: 1
Combination of SU011248 (37.5 mg once daily [Schedule 2/1]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
Interventions:
  • Drug: Herceptin
  • Drug: Sunitinib
  • Drug: Taxotere
Publications * Cardoso F, Canon JL, Amadori D, Aldrighetti D, Machiels JP, Bouko Y, Verkh L, Usari T, Kern KA, Giorgetti C, Dirix L. An exploratory study of sunitinib in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive metastatic breast cancer. Breast. 2012 Dec;21(6):716-23. doi: 10.1016/j.breast.2012.09.002. Epub 2012 Sep 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2011)
26
Original Enrollment  ICMJE
 (submitted: September 5, 2006)
20
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
  • Tumors over-expressing Her-2
  • Candidate for treatment with docetaxel/trastuzumab

Exclusion Criteria:

  • Histology of inflammatory carcinoma
  • AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372424
Other Study ID Numbers  ICMJE A6181113
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP