NCT00788931

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
5 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Last Updated

December 19, 2020

Status Verified

November 1, 2012

Enrollment Period

1.7 years

First QC Date

October 24, 2008

Last Update Submit

December 16, 2020

Conditions

HER-2 Positive Breast CancerMetastatic Breast Cancer

Keywords

Breast CancerHER2 positiveadult-femaleLBH589HDAC inhibitorpanobinostatmetastatic breastadult female patients

Outcome Measures

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.

    At least 21 day cycle for both arms

Secondary Outcomes (2)

  • Safety and tolerability throughout the study for both IV and oral arms to determine the recommended dose for phase ll trials.

    4 weeks after end of treatment

  • To evaluate the efficacy in the expansion phase of the trial when the MTD is defined.

    throughout the study and 4 weeks after end of treatment

Study Arms (2)

IV LBH589 + trastuzumab + paclitaxel

EXPERIMENTAL

i.v. panobinostat

Drug: IV LBH589Drug: trastuzumabDrug: paclitaxel

Oral LBH589 + trastuzumab + paclitaxel

EXPERIMENTAL

oral panobinostat

Drug: IV LBH589Drug: Oral LBH589Drug: trastuzumabDrug: paclitaxel

Interventions

IV LBH589DRUG
IV LBH589 + trastuzumab + paclitaxelOral LBH589 + trastuzumab + paclitaxel
Oral LBH589DRUG
Oral LBH589 + trastuzumab + paclitaxel
trastuzumabDRUG
IV LBH589 + trastuzumab + paclitaxelOral LBH589 + trastuzumab + paclitaxel
paclitaxelDRUG
IV LBH589 + trastuzumab + paclitaxelOral LBH589 + trastuzumab + paclitaxel

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Novartis Investigative Site

Mobile, Alabama, 36688, United States

Location

Novartis Investigative Site

Woodville, South Australia, 5011, Australia

Location

Novartis Investigative Site

Brussels, 1000, Belgium

Location

Novartis Investigative Site

Liège, 4000, Belgium

Location

Novartis Investigative Site

Macerata, MC, 62100, Italy

Location

Novartis Investigative Site

Aviano, PN, 33081, Italy

Location

Novartis Investigative Site

Amsterdam, 1066 CX, Netherlands

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

PanobinostatTrastuzumabPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 24, 2008

First Posted

November 11, 2008

Study Start

December 1, 2008

Primary Completion

August 1, 2010

Last Updated

December 19, 2020

Record last verified: 2012-11

Locations

IT(2)NL(1)AU(1)BE(2)US(1)