A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00788931
First received: October 24, 2008
Last updated: November 26, 2012
Last verified: November 2012

October 24, 2008
November 26, 2012
December 2008
August 2010   (final data collection date for primary outcome 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. [ Time Frame: At least 21 day cycle for both arms ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00788931 on ClinicalTrials.gov Archive Site
  • Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials. [ Time Frame: 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]
  • To evaluate the efficacy in the expansion phase of the trial when the MTD is defined. [ Time Frame: throughout the study and 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer
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)

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HER-2 Positive Breast Cancer
  • Metastatic Breast Cancer
  • Drug: IV LBH589
  • Drug: Oral LBH589
  • Drug: trastuzumab
  • Drug: paclitaxel
  • Experimental: IV LBH589 + trastuzumab + paclitaxel
    i.v. panobinostat
    Interventions:
    • Drug: IV LBH589
    • Drug: trastuzumab
    • Drug: paclitaxel
  • Experimental: Oral LBH589 + trastuzumab + paclitaxel
    oral panobinostat
    Interventions:
    • Drug: IV LBH589
    • Drug: Oral LBH589
    • Drug: trastuzumab
    • Drug: paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
Not Provided
August 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Italy,   Netherlands
 
NCT00788931
CLBH589C2114, 2007-004788-23
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP