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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Herceptin (Drug); Sunitinib (Drug); Taxotere (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

Secondary outcome:

Percentage of Participants With Objective Response (OR)

Progression-free Survival (PFS)

Duration of Response (DR)

Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)

Maximum Observed Plasma Concentration (Cmax) of Docetaxel

Plasma Trough Concentrations (Ctrough) of Trastuzumab

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Pfizer Investigational Site, Bruxelles 1000, Belgium

Pfizer Investigational Site, Bruxelles 1200, Belgium

Pfizer Investigational Site, Charleroi 6000, Belgium

Pfizer Investigational Site, Sint-Niklaas 9100, Belgium

Pfizer Investigational Site, Wilrijk 2610, Belgium

Pfizer Investigational Site, Milano 20132, Italy

Pfizer Investigational Site, Meldola, FC 47014, Italy

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2006
Last updated: December 21, 2012

Page last updated: August 23, 2015

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