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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00788931
Other study ID # CLBH589C2114
Secondary ID 2007-004788-23
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2008

Study information

Verified date November 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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

Study Design


Intervention

Drug:
IV LBH589

Oral LBH589

trastuzumab

paclitaxel


Locations

Country Name City State
Australia Novartis Investigative Site Woodville South Australia
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Liege
Italy Novartis Investigative Site Aviano PN
Italy Novartis Investigative Site Macerata MC
Netherlands Novartis Investigative Site Amsterdam
United States Novartis Investigative Site Mobile Alabama

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At least 21 day cycle for both arms
Secondary Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials. 4 weeks after end of treatment
Secondary To evaluate the efficacy in the expansion phase of the trial when the MTD is defined. throughout the study and 4 weeks after end of treatment
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