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

December 16, 2020 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Novartis Investigative Site
  • Belgium
      • Bruxelles, Belgium, 1000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
  • Italy
    • MC
      • Macerata, MC, Italy, 62100
        • Novartis Investigative Site
    • PN
      • Aviano, PN, Italy, 33081
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Novartis Investigative Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36688
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IV LBH589 + trastuzumab + paclitaxel
i.v. panobinostat
Drug: paclitaxel
Drug: trastuzumab
Drug: IV LBH589
EXPERIMENTAL: Oral LBH589 + trastuzumab + paclitaxel
oral panobinostat
Drug: paclitaxel
Drug: trastuzumab
Drug: IV LBH589
Drug: Oral LBH589

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At least 21 day cycle for both arms

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks after end of treatment
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
throughout the study and 4 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

October 24, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (ESTIMATE)

November 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLBH589C2114
  • 2007-004788-23 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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