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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
History of Changes
  Purpose

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


Condition Intervention Phase
HER-2 Positive Breast Cancer
Metastatic Breast Cancer
 Drug: IV LBH589
Drug: Oral LBH589
Drug: trastuzumab
Drug: paclitaxel
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: December 2008
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV LBH589 + trastuzumab + paclitaxel
i.v. panobinostat
 Drug: IV LBH589 Drug: trastuzumab Drug: paclitaxel
Experimental: Oral LBH589 + trastuzumab + paclitaxel
oral panobinostat
 Drug: IV LBH589 Drug: Oral LBH589 Drug: trastuzumab Drug: paclitaxel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788931

Locations
United States, Alabama
Novartis Investigative Site
Mobile, Alabama, United States, 36688
Australia, South Australia
Novartis Investigative Site
Woodville, South Australia, Australia, 5011
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1000
Novartis Investigative Site
Liege, Belgium, 4000
Italy
Novartis Investigative Site
Macerata, MC, Italy, 62100
Novartis Investigative Site
Aviano, PN, Italy, 33081
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1066 CX
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00788931     History of Changes
Other Study ID Numbers: CLBH589C2114, 2007-004788-23
Study First Received: October 24, 2008
Last Updated: November 26, 2012
Health Authority: United States: Food and Drug Administration
Australia: National Health and Medical Research Council
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Sweden: The National Board of Health and Welfare

Keywords provided by Novartis:
Breast Cancer
HER2 positive
adult-female
LBH589
 HDAC inhibitor
panobinostat
metastatic breast
adult female patients

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013