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Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00967044
First received: August 25, 2009
Last updated: September 2, 2014
Last verified: September 2014
Results First Received: September 2, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: Panobinostat
Drug: Everolimus

  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
Recruitment Period: November 25, 2009 to February 17, 2012. All recruitment was done at University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 31 participants recruited, one participant was excluded from the study as a screen failure.

Reporting Groups
  Description
Panobinostat + Everolimus

Panobinostat (LBH589) Plus Everolimus (RAD001)

Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week

Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal.


Participant Flow:   Overall Study
    Panobinostat + Everolimus  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     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.
A total of 30 patients were evaluated in intention to treat based response analysis.

Reporting Groups
  Description
Panobinostat + Everolimus

Panobinostat (LBH589) Plus Everolimus (RAD001)

Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by participants), three times per week.

Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal.


Baseline Measures
    Panobinostat + Everolimus  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Median ( Full Range )
  52  
  ( 20 to 74 )  
Gender  
[units: participants]
 
Female     8  
Male     22  
Region of Enrollment  
[units: participants]
 
United States     30  
Participation by Cohort [1]
[units: participants]
 
Panobinostat 10 mg/Everolimus 5 mg     3  
Panobinostat 20 mg/Everolimus 5 mg     3  
Panobinostat 20 mg/Everolimus 10 mg     22  
Panobinostat 30 mg/Everolimus 10 mg     2  
[1] Participant by Cohort (1 to 4) according to Panobinostat dose (mg/orally taken three times weekly) and Everolimus dose (mg/orally taken daily).



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Everolimus With Panobinostat   [ Time Frame: 28 day treatment cycle ]


  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
Initially intended to proceed to phase II at MTD, treatment interruptions were frequently required in participants treated at MTD for Grade 3/4 Thrombocytopenia so study amended to obtain more detailed safety data at MTD in expanded phase I study.


  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: Yasuhiro Oki, MD / Assistant Professor, Lymphoma/Myeloma
Organization: University of Texas MD Anderson Cancer Center
phone: 713-792-2860
e-mail: CR_Study_Registration@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00967044     History of Changes
Other Study ID Numbers: 2008-0805, NCI-2011-03023
Study First Received: August 25, 2009
Results First Received: September 2, 2014
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration