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Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Montgomery, Alabama, 36106 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or
2) metastatic disease.

- HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)

- Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/
lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted.
Treatment with hormone therapy in the adjuvant and/or advanced disease setting is
permitted.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting.
Adjuvant chemotherapy is permitted

- Prior exposure to trastuzumab if the patient had developed severe hypersensitivity
reactions.

- Prior treatment on a SU11248 clinical trial.

- Uncontrolled brain metastases.

NCT00243503
Pfizer
Completed
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

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Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
A Phase 2 Efficacy And Safety Study Of SU011248 In Combination With Trastuzumab As Treatment For Metastatic Disease In Patients With Breast Cancer
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
Drug: SU011248/Trastuzumab
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
Experimental: A
Intervention: Drug: SU011248/Trastuzumab
Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
July 2010
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
  • HER2 positive disease (3+ by immunohistochemistry [IHC] or FISH-positive)
  • Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion Criteria:

  • Prior treatment with >1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
  • Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
  • Prior treatment on a SU11248 clinical trial.
  • Uncontrolled brain metastases.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Spain,   United States
 
 
NCT00243503
A6181067
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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