Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372424
• Other study ID #: A6181113
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2006
• Last updated: December 21, 2012
• Start date: December 2006
• Est. completion date: September 2011

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Charleroi
Belgium	Pfizer Investigational Site	Sint-Niklaas
Belgium	Pfizer Investigational Site	Wilrijk
Italy	Pfizer Investigational Site	Meldola	FC
Italy	Pfizer Investigational Site	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum Observed Plasma Concentration (Cmax) of Paclitaxel		End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6	No
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	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.	From screening until 28 days post last dose of study drug	Yes
Secondary	Percentage of Participants With Objective Response (OR)	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.	Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)	No
Secondary	Progression-free Survival (PFS)	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").	Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)	No
Secondary	Duration of Response (DR)	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.	Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)	No
Secondary	Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)	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.	Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1	No
Secondary	Maximum Observed Plasma Concentration (Cmax) of Docetaxel	Concentration values below the lower limit of quantification were taken as zero.	End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6	No
Secondary	Plasma Trough Concentrations (Ctrough) of Trastuzumab	Ctrough = the concentration prior to study medication administration.	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	No

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