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A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas (PXD101-CLN-6)

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ClinicalTrials.gov Identifier: NCT00274651
Recruitment Status : Terminated (Enrollment stopped prior to reaching expected number of patients, study had accumulated sufficient data to allow a registration study in PTCL (PXD101-CLN-19))
First Posted : January 11, 2006
Results First Posted : October 27, 2014
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Onxeo

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cutaneous T-Cell Lymphoma
Peripheral T-Cell Lymphoma
Non-Hodgkin's Lymphoma
Intervention: Drug: belinostat

  Participant Flow

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
Arm A (CTCL, ITT Population) PXD101 1000 mg/m2 once daily for 5 days every 21 days
Arm B (PTCL, ITT Population) PXD101 1000 mg/m2 once daily for 5 days every 21 days

Participant Flow:   Overall Study
    Arm A (CTCL, ITT Population)   Arm B (PTCL, ITT Population)
STARTED   29   24 
COMPLETED   1   4 
NOT COMPLETED   28   20 
Adverse Event                6                3 
Lack of Efficacy                13                6 
Death                1                3 
Withdrawal by Subject                0                1 
Physician Decision                8                7 



  Baseline Characteristics

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.
Patients received PXD101, 1000 mg/m2/day over 30 minutes days 1-5 of a 21-day cycle. Patients with OR or stable disease were permitted to continue with PXD101 for up to 8 cycles or until progressive disease. Patients with PR or SD could continue therapy beyond 8 cycles until progression in consultation with Investigators and Sponsor.

Reporting Groups
  Description
CTCL (ITT Population)

CTCL patients will receive 1000 mg/m2 of PXD101 IV

belinostat: 1000 mg/m2 for 5 days every 21 days; IV

PTCL (ITT Population)

PTCL patients will receive 1000 mg/m2 of PXD101 IV

belinostat: 1000 mg/m2 for 5 days every 21 days; IV

Total Total of all reporting groups

Baseline Measures
   CTCL (ITT Population)   PTCL (ITT Population)   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   24   53 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (13.4)   58.8  (15.9)   61.7  (14.7) 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   12   12   24 
>=65 years   17   12   29 
Gender 
[Units: Participants]
     
Female   15   7   22 
Male   14   17   31 
Region of Enrollment 
[Units: Participants]
     
United States   22   17   39 
France   2   0   2 
Israel   2   1   3 
Thailand   2   6   8 
Germany   1   0   1 


  Outcome Measures

1.  Primary:   Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)   [ Time Frame: throughout the study, or for a maximum of 2 years ]

2.  Primary:   Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))   [ Time Frame: throughout the study, or for a maximum of 2 years ]

3.  Secondary:   Time to Progression   [ Time Frame: throughout the study, or for a maximum of 2 years ]

4.  Secondary:   Time to Response   [ Time Frame: throughout the study, or for a maximum of 2 years ]

5.  Secondary:   Duration of Response   [ Time Frame: throughout the study, or for a maximum of 2 years ]

6.  Post-Hoc:   Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)   [ Time Frame: throughout the study, or for a maximum of 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: PRS Admnistrator Gunilla Emanuelson
Organization: Topotarget A/S
phone: +45 39 17 83 92
e-mail: enquiries@topotarget.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Onxeo
ClinicalTrials.gov Identifier: NCT00274651     History of Changes
Other Study ID Numbers: PXD101-CLN-6
First Submitted: January 10, 2006
First Posted: January 11, 2006
Results First Submitted: June 30, 2014
Results First Posted: October 27, 2014
Last Update Posted: July 28, 2015