A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab

NCT00567879 | Terminated Phase 1 Results

• 2 other identifiers: CLBH589C22042007-002449-19
• Study Type: interventional
• Target: 56
• Locations: 6 countries
• Sites: 20

Brief Summary

The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer

Conditions

Breast Cancer

Keywords

Breast Cancer; HER2 positive; adult-female; LBH589; HDAC inhibitor; panobinostat

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicities (DLTs)

  Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.

  day 21

Secondary Outcomes (1)

• Number of Participants With Best Overall Response

  day 21

Study Arms (1)

Panobinostat with trastuzumab

EXPERIMENTAL

Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.

Drug: Panobinostat; Drug: Trastuzumab

Interventions

Panobinostat DRUG

Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m\^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly.

Panobinostat with trastuzumab

Trastuzumab DRUG

Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.

Also known as: Herceptin

Panobinostat with trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

University of Colorado Dept. of Univ. of Colorado

Aurora, Colorado, 80045, United States

Location

Norwalk Hospital Dept of Norwalk Hospital (2)

Norwalk, Connecticut, 06856, United States

Location

VA Maryland Health Care Dept.of GreenbaumCancerCent(3)

Baltimore, Maryland, 21201, United States

Location

The Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

Ohio State Comprehensive Cancer Center/James Cancer Hospital SC

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Novartis Investigative Site

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1E2, Canada

Location

Novartis Investigative Site

Dijon, 21034, France

Location

Novartis Investigative Site

Paris, 75231, France

Location

Novartis Investigative Site

Saint-Herblain Cédex, 44805, France

Location

Novartis Investigative Site

Heidelberg, 69115, Germany

Location

Novartis Investigative Site

Meldola, FC, 47014, Italy

Location

Novartis Investigative Site

Genova, GE, 16132, Italy

Location

Novartis Investigative Site

Modena, MO, 41100, Italy

Location

Novartis Investigative Site

Birmingham, B15 2TH, United Kingdom

Location

Novartis Investigative Site

London, W12 0HS, United Kingdom

Location

Novartis Investigative Site

Manchester, M20 4BX, United Kingdom

Location

Related Links

• Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Panobinostat; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2007
• Study Start: April 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 9, 2016
• Results First Posted: May 9, 2016

Record last verified: 2016-03

Locations

GB (3); US (7); DE (1); CA (3); FR (3); IT (3)