A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.
- Conditions
- Solid tumor and ErbB2 negative locally advanced or metastatic breast cancerMedDRA version: 12.0Level: LLTClassification code 10027475Term: Metastatic breast cancer
- Registration Number
- EUCTR2009-011878-15-FR
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 152
• Part 1 only: Subjects with confirmed pathologic diagnosis of advanced breast cancer or pancreatic cancer or colorectal cancer or cholangiocarcinoma or glioblastoma that is not curable with available therapies, for whom bosutinib plus capecitabine is a reasonable treatment option.
• Part 2 only: Subjects with 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.
• Part 2 only: Documented ER+ and/or PgR+/erbB2- (Arm A only) or ER-/PgR-/erbB2- (Arm B only) tumor based on most recently analyzed biopsy, as documented by a local laboratory.
• Part 2 only: Subjects must have received at least one but no more than 2 prior cytotoxic chemotherapy regimens for metastatic breast cancer.
• Parts 1 & 2: At least 1 radiologically measurable lesion as defined by RECIST v1.0.
• Part 2 only: Availability of formalin-fixed paraffin embedded (FFPE) tumor tissue block preferably or alternatively unstained slides for exploratory biomarker analysis.
• Parts 1 & 2: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Parts 1 & 2: Prior bosutinib, or any other prior Src inhibitor.
• Part 1 only: Prior chemotherapy with capecitabine or 5-fluorouracil (5-FU) for the treatment of metastatic disease is allowed unless patient stopped therapy for toxicity (including but not limited to hand and foot syndrome, grade 3/4 diarrhea, etc).
• Part 2 only: Prior chemotherapy with capecitabine or 5-FU for the treatment of metastatic disease.
• Part 2 only: Prior chemotherapy with capecitabine or 5-FU for adjuvant chemotherapy within the past 12 months
• Part 2 only: erbB2+ breast cancer
• Parts 1 & 2: Cytotoxic chemotherapy, investigational therapy, major surgery or radiation therapy within 14 days of treatment day 1.
• Parts 1 & 2: Bone or skin as the only site of disease.
• Parts 1 & 2: Clinically unstable primary or metastatic central nervous system (CNS) tumors. Subjects with progression of CNS tumors are eligible as long as they have been clinically stable for at least 4 weeks prior to first dose of bosutinib and capecitabine (ie, no significant change in anticonvulsant or corticosteroid doses, mental status, or clinical symptoms).
• Part 2 only: Any other cancer within 5 years before screening with the exception of adequately treated cervical cancer in situ, or adequately treated basal or squamous cell cancer of the skin.
• Parts 1 & 2: Inadequate hepatic/renal/bone marrow function.
• Parts 1 & 2: History of clinically significant or uncontrolled cardiac disease.
• Parts 1 & 2: Serious concurrent illness.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method