A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
Tracking Information
Start Date ICMJE | December 2008 |
---|---|
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: November 10, 2008) | Determine the maximum tolerated dose of oral panobinostat in combination with trastuzumab and paclitaxel. Determine the maximum tolerated dose of iv LBH in combination with trastuzumab and paclitaxel. [ Time Frame: At least 21 day cycle for both arms ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00788931 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 10, 2008) |
|
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer |
---|---|
Official Title ICMJE | A Phase Ib, Open-label, Two Arm Study of i.v. and Oral Panobinostat (LBH589) in Combination With i.v. Trastuzumab (Herceptin®) and i.v. Paclitaxel as Treatment for Adult Female Patients With HER2 Overexpressing Metastatic Breast Cancer (MBC) |
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 evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer |
Detailed Description | |
Study Phase | Phase I, Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment |
Condition ICMJE |
|
Intervention ICMJE | Drug: panobinostat in combination with trastuzumab and paclitaxel |
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 52 | ||||
---|---|---|---|---|---|
Completion Date | |||||
Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | Australia, Belgium, Netherlands, Russian Federation, Sweden |
Administrative Information
NCT ID ICMJE | NCT00788931 | ||||
---|---|---|---|---|---|
Responsible Party | External Affairs, Novartis Pharmaceuticals | ||||
Study ID Numbers ICMJE | CLBH589C2114, EudraCT 2007-004788-23 | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | Novartis |
Source: http://clinicaltrials.gov/