Status:
COMPLETED
Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a world wide phase 1/2, open-label, study of neratinib in combination with capecitabine, conducted in 2 parts. In Part 1, 3 to 9 subjects with solid tumors will be enrolled in each dose group...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- PART 1:
- confirmed pathologic diagnosis of a solid tumor not curable with available therapies for which neratinib plus capecitabine is a reasonable treatment option.
- PART 2:
- confirmed histologically and/or cytologically confirmed diagnosis of breast cancer, metastatic or locally advanced.
- erbB-2 gene amplified tumor (FISH or CISH) or erbB-2 overexpression (IHC 3+, or IHC2+ with FISH or CISH confirmation), based on local testing, or based on centralized FISH testing prior to day 1.
- disease progression on or following at least 1 prior trastuzumab containing treatment regimen (at least 6 weeks) for metastatic or locally advanced disease. (Prior adjuvant trastuzumab is allowed but not required). A 2 week period is required between the last dose of trastuzumab treatment and first dose of the test article.
- Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, and/or metastatic disease treatment setting.
- PARTS 1 and 2:
- At least 1 measurable lesion as defined by RECIST criteria.
- LVEF within institutional range of normal as measured by multi-gated acquisition (MUGA) or echocardiogram (ECHO).
- EXCLUSION CRITERIA
- PART 2:
- prior treatment with capecitabine, lapatinib (20 subjects with prior lapatinib exposure will be enrolled) or any erbB-2 targeted agents except trastuzumab. Treatment with erbB-2 targeted therapy must exceed 2 weeks (14 days) in order to be exclusionary.
- prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m², epirubicin dose of greater than 800 mg/m², or the equivalent dose for other anthracyclines.
- PARTS 1 and 2:
- Subjects with bone as the only site of disease.
- Active uncontrolled or symptomatic central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Subjects with a history of CNS metastases or cord compression are allowable if they have been considered definitively treated and are off anticonvulsants and steroids for at least 4 weeks before the first dose of test article.
- Any other cancer within 5 years prior to screening with the exception of adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
Exclusion
Key Trial Info
Start Date :
December 9 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00741260
Start Date
December 9 2008
End Date
June 1 2018
Last Update
September 5 2018
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
USA Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
2
Pacific Shores Medical Group
Long Beach, California, United States, 90813
3
University of Southern California
Los Angeles, California, United States, 90033
4
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804