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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

This study has been terminated.
(The study was terminated early due to insufficient evidence of clinical benefit.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00567879
First received: December 4, 2007
Last updated: April 4, 2016
Last verified: March 2016
Results First Received: April 4, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Panobinostat
Drug: Trastuzumab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible participants were allocated to dose escalation arm 1 (i.v. panobinostat) or arm 2 (oral panobinostat) according to a pre-determined sequence in the ratio 1:1. Each cohort consisted of newly enrolled participants. This study included a dose escalation phase to establish the maximum tolerated dose (MTD) and a dose expansion phase.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Escalation: i.v. Arm - 10mg/m^2 10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation: i.v. Arm - 15mg/m^2 15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation/Expansion: i.v. Arm -20mg/m^2 20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Oral Arm - Schedule A 20mg 20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 15 mg 15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 20mg 20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.

Participant Flow:   Overall Study
    Escalation: i.v. Arm - 10mg/m^2     Escalation: i.v. Arm - 15mg/m^2     Escalation/Expansion: i.v. Arm -20mg/m^2     Oral Arm - Schedule A 20mg     Oral Arm - Schedule B 15 mg     Oral Arm - Schedule B 20mg  
STARTED     7     7     21 [1]   6     12     3  
Maximum Tolerated Dose Determining Set     5     7     18 [2]   6     12     3  
COMPLETED     0     0     0     0     0     0  
NOT COMPLETED     7     7     21     6     12     3  
Adverse Event                 2                 0                 1                 0                 1                 0  
Abnormal test procedure(s)                 0                 0                 1                 0                 0                 0  
Withdrawal by Subject                 0                 0                 3                 1                 0                 0  
New cancer therapy                 0                 0                 1                 0                 0                 0  
Disease progression                 5                 7                 15                 5                 11                 3  
[1] 7 participants belonged to the dose expansion group at 20mg/m2 i.v.
[2] 6 participants belonged to the dose expansion group at 20mg/m2 i.v.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Escalation: i.v. Arm - 10mg/m^2 10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation: i.v. Arm - 15mg/m^2 15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation/Expansion: i.v. Arm -20mg/m^2 20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Oral Arm - Schedule A 20mg 20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 15mg 15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 20mg 20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
Total Total of all reporting groups

Baseline Measures
    Escalation: i.v. Arm - 10mg/m^2     Escalation: i.v. Arm - 15mg/m^2     Escalation/Expansion: i.v. Arm -20mg/m^2     Oral Arm - Schedule A 20mg     Oral Arm - Schedule B 15mg     Oral Arm - Schedule B 20mg     Total  
Number of Participants  
[units: participants]
  7     7     21     6     12     3     56  
Age  
[units: Years]
Median (Full Range)
  58.0  
  (35.0 to 60.0)  
  49.0  
  (33.0 to 60.0)  
  57.0  
  (37.0 to 83.0)  
  54.5  
  (49.0 to 59.0)  
  53.5  
  (40.0 to 65.0)  
  47.0  
  (38.0 to 60.0)  
  53.0  
  (33.0 to 83.0)  
Gender, Customized  
[units: Participants]
             
Female     7     7     21     6     12     3     56  



  Outcome Measures
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1.  Primary:   Number of Participants With Dose Limiting Toxicities (DLTs)   [ Time Frame: day 21 ]

2.  Secondary:   Number of Participants With Best Overall Response   [ Time Frame: day 21 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00567879     History of Changes
Other Study ID Numbers: CLBH589C2204
2007-002449-19 ( EudraCT Number )
Study First Received: December 4, 2007
Results First Received: April 4, 2016
Last Updated: April 4, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency