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A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab

Inclusion Criteria


Inclusion criteria:

- Age > 18 year old

- Confirmed HER2+ ve metastatic breast cancer

- Prior treatment and progression on trastuzumab

- Patients must have adequate laboratory values

- Eastern Cooperative Oncology Group (ECOG) performance status of <2

Exclusion criteria:

- Patients with active central nervous system (CNS) disease or brain metastases except
those who have been previously treated and have been stable for at least 3 months.

- Impaired heart function or clinically significant heart disease

- Impairment of gastrointestinal (GI) function, or GI disease that may significantly
alter the absorption of LBH589

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the dose of oral panobinostat plus trastuzumab combination

Outcome Time Frame:

throughout the study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CLBH589C2204

NCT ID:

NCT00567879

Start Date:

April 2008

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • HER2 positive
  • adult-female
  • LBH589
  • HDAC inhibitor
  • panobinostat
  • Breast Neoplasms

Name

Location

Novartis Investigative SitePhiladelphia, Pennsylvania  19111-2497
Novartis Investigative SiteSacramento, California  95817
Novartis Investigative SiteSt. Louis, Missouri  63110
Novartis Investigative SiteCleveland, Ohio  44195
Novartis Investigative SiteDenver, Colorado  80218
Novartis Investigative SiteBaltimore, Maryland  21201
Novartis Investigative SiteNorwalk, Connecticut  06856