Study Of Bosutinib With Capecitabine In Solid Tumors And Locally Advanced Or Metastatic Breast Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Advanced Breast Cancer (Parts 1 and 2), Advanced Pancreatic Cancer (Part 1), Advanced Colorectal Cancer (Part 1), Advanced Cholangiocarcinoma (Part 1), Advanced Glioblastoma Multiforme (Part 1)
In brief
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 handles the study drug, and preliminary anti-tumor activity as treatment for different types of cancers in part 1, and breast cancer only in part 2. In part 1, subjects will receive bosutinib and capecitabine daily at different dose levels of each drug in order to determine the highest tolerated dose of the combination study treatment. In part 2, subjects will receive bosutinib and capecitabine at this highest tolerated dose to see how well the study treatment works to treat breast cancer. In addition, genetic research testing (research analyses involving genes and gene products) will be performed on biological samples from subjects.
Key facts
- Study ID
- NCT00959946
- Run by
- Pfizer
- People needed
- 32
- Starts
- 2009-09-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2013-02-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Boston, Massachusetts, United States
- Pfizer Investigational Site — Detroit, Michigan, United States
- Pfizer Investigational Site — Adelaide, South Australia, Australia
- Pfizer Investigational Site — Edegem, Belgium
- Pfizer Investigational Site — Saint-Herblain, France
- Pfizer Investigational Site — Hong Kong, Hong Kong
- Pfizer Investigational Site — Madrid, Madrid, Spain
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.