Status:
COMPLETED
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
HER-2 Positive Breast Cancer
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat when given in combination with trastuzumab and paclitaxel. The study will ev...
Eligibility Criteria
Inclusion
- Age \> 18 year old
- Confirmed HER2+ metastatic breast cancer
- Prior treatment and progression on trastuzumab
- Patients must have adequate organ functions
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Exclusion
- Patients who have had surgery within last 2 weeks prior to starting the treatment
- Patients who receive concurrent therapy for brain metastases
- Impaired heart function or clinically significant heart disease
- Ongoing diarrhea
- Liver or renal disease with impaired hepatic or renal functions
- Concomitant use of any anti-cancer therapy or certain drugs
- Female patients who are pregnant or breast feeding
- Patients not willing to use an effective method of birth control Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00788931
Start Date
December 1 2008
Last Update
December 19 2020
Active Locations (7)
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1
Novartis Investigative Site
Mobile, Alabama, United States, 36688
2
Novartis Investigative Site
Woodville, South Australia, Australia, 5011
3
Novartis Investigative Site
Brussels, Belgium, 1000
4
Novartis Investigative Site
Liège, Belgium, 4000