Clinical trial NCT00788931: A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HER-2 Positive Breast Cancer
Metastatic Breast Cancer
Keywords: Breast Cancer
HER2 positive
adult-female
LBH589
HDAC inhibitor
panobinostat
metastatic breast
adult female patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: At least 21 day cycle for both arms
Secondary outcomes:
measure: Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.
timeFrame: 4 weeks after end of treatment
measure: To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.
timeFrame: throughout the study and 4 weeks after end of treatment
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Woodville
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Macerata
country: Italy
facility: Novartis Investigative Site
state: MC
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: