The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00788931




Registration number
NCT00788931
Ethics application status
Date submitted
24/10/2008
Date registered
11/11/2008
Date last updated
27/11/2012

Titles & IDs
Public title
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
Scientific 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)
Secondary ID [1] 0 0
2007-004788-23
Secondary ID [2] 0 0
CLBH589C2114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HER-2 Positive Breast Cancer 0 0
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IV LBH589
Treatment: Drugs - Oral LBH589
Treatment: Drugs - trastuzumab
Treatment: Drugs - paclitaxel

Experimental: IV LBH589 + trastuzumab + paclitaxel - i.v. panobinostat

Experimental: Oral LBH589 + trastuzumab + paclitaxel - oral panobinostat


Treatment: Drugs: IV LBH589


Treatment: Drugs: Oral LBH589


Treatment: Drugs: trastuzumab


Treatment: Drugs: paclitaxel


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
At least 21 day cycle for both arms
Secondary outcome [1] 0 0
Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.
Timepoint [1] 0 0
4 weeks after end of treatment
Secondary outcome [2] 0 0
To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.
Timepoint [2] 0 0
throughout the study and 4 weeks after end of treatment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Woodville
Recruitment postcode(s) [1] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Belgium
State/province [3] 0 0
Liege
Country [4] 0 0
Italy
State/province [4] 0 0
MC
Country [5] 0 0
Italy
State/province [5] 0 0
PN
Country [6] 0 0
Netherlands
State/province [6] 0 0
Amsterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT00788931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications