Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies (SAHA)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Owen A. O'Connor, Columbia University
ClinicalTrials.gov Identifier:
NCT00691210
First received: June 3, 2008
Last updated: August 17, 2015
Last verified: August 2015
Results First Received: March 7, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Hodgkin's Disease
Non-Hodgkin's Lymphoma
Interventions: Drug: Vorinostat
Drug: Niacinamide
Drug: Etoposide

  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
No text entered.

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
V/N: Level 2

Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 1

Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 3

Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 4

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 5

Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N/E: Level 1

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

V/N/E: Level 2

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

V/N/E: Level 3

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme


Participant Flow:   Overall Study
    V/N: Level 2     V/N: Level 1     V/N: Level 3     V/N: Level 4     V/N: Level 5     V/N/E: Level 1     V/N/E: Level 2     V/N/E: Level 3  
STARTED     3     5     3     9     5     7     6     0  
COMPLETED     3     5     3     6     5     6     6     0  
NOT COMPLETED     0     0     0     3     0     1     0     0  
Progression of Disease                 0                 0                 0                 2                 0                 0                 0                 0  
Lack of Efficacy                 0                 0                 0                 1                 0                 1                 0                 0  



  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
V/N: Level 2

Vorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 1

Vorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 3

Vorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 4

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N: Level 5

Vorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg

Vorinostat (SAHA) and Niacinamide: dose escalation scheme

V/N/E: Level 1

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

V/N/E: Level 2

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

V/N/E: Level 3

Vorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2

Vorinostat, Niacinamide and Etoposide: dose escalation scheme

Total Total of all reporting groups

Baseline Measures
    V/N: Level 2     V/N: Level 1     V/N: Level 3     V/N: Level 4     V/N: Level 5     V/N/E: Level 1     V/N/E: Level 2     V/N/E: Level 3     Total  
Number of Participants  
[units: participants]
  3     5     3     9     5     7     6     0     38  
Age  
[units: participants]
                 
<=18 years     0     0     0     0     0     0     0         0  
Between 18 and 65 years     2     5     3     7     3     6     4         30  
>=65 years     1     0     0     2     2     1     2         8  
Gender  
[units: participants]
                 
Female     2     2     1     4     2     2     2         15  
Male     1     3     2     5     3     5     4         23  



  Outcome Measures
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1.  Primary:   The Maximum Tolerated Dose of Niacinamide in the Combination of Vorinostat and Niacinamide   [ Time Frame: 3 years ]

2.  Secondary:   The Greatest Number of Cycles Received in Each Treatment Group   [ Time Frame: up to 45 weeks ]

3.  Secondary:   The Number of Dose Delays and Reductions at the MTD   [ Time Frame: continuous ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   The Prevalence of Anti-tumor Activity   [ Time Frame: continuous ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies   [ Time Frame: continuous ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Owen A. O'Connor, MD, Ph.D.
Organization: Columbia University Medical Center
phone: 212-326-5720
e-mail: oo2130@cumc.columbia.edu


No publications provided by Columbia University

Publications automatically indexed to this study:

Responsible Party: Owen A. O'Connor, Columbia University
ClinicalTrials.gov Identifier: NCT00691210     History of Changes
Other Study ID Numbers: AAAJ3001
Study First Received: June 3, 2008
Results First Received: March 7, 2014
Last Updated: August 17, 2015
Health Authority: United States: Institutional Review Board