Status:
TERMINATED
Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Advanced Breast Cancer (Parts 1 and 2)
Advanced Pancreatic Cancer (Part 1)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a research study in 2 parts assessing the following parameters of the combination of the study drug called bosutinib, and a drug called capecitabine: the safety, how well the subject's body ha...
Detailed Description
The study was prematurely discontinued following Part 1 evaluation, when the sponsor concluded that further translational biomarker analyses were needed to better define the breast tumor biomarkers th...
Eligibility Criteria
Inclusion
- Part 1:
- Ages eligible for study: 18 years or older.
- Male and female.
- Confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or colorectal cancer or cholangiocarcinoma or glioblastoma not curable with available therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.
- Part 2:
- Ages eligible for study: 18 years or older.
- Female.
- Confirmed pathologic diagnosis of locally advanced or metastatic breast cancer, or loco-regional recurrent breast cancer that is not amenable to curative treatment with surgery or radiotherapy.
- Documented ER+ and/or PgR+/erbB2- or ER-/PgR-/erbB2- tumor based upon recently analyzed biopsy.
Exclusion
- Part 1:
- Prior bosutinib, or any other prior Src inhibitor.
- Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease is allowed unless patient stopped therapy for toxicity.
- Part 2:
- Prior bosutinib, or any other prior Src inhibitor prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease.
- Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the past 12 months.
- erbB2+ breast cancer.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00959946
Start Date
September 1 2009
End Date
March 1 2011
Last Update
February 22 2013
Active Locations (7)
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1
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
2
Pfizer Investigational Site
Detroit, Michigan, United States, 84202
3
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5037
4
Pfizer Investigational Site
Edegem, Belgium, 2650