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OpenTrials
Completed

NCT Number: NCT00788931

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

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

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Key information

Conditions

HER-2 Positive Breast Cancer Breast Diseases Breast Neoplasms Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Woodville, South Australia, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV LBH589

Drug

Oral LBH589

Drug

Trastuzumab

Drug

paclitaxel

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2010
First posted
Nov 11, 2008
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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