A Phase II Study to Evaluate Efficacy and Safety of P276-00 in Relapsed and/or Refractory Mantle Cell Lymphoma

This study has been terminated.
(The study was terminated based on interim results and all subjects were off study at that time. No major safety or tolerability concerns)
Sponsor:
Information provided by (Responsible Party):
Piramal Enterprises Limited
ClinicalTrials.gov Identifier:
NCT00843050
First received: February 12, 2009
Last updated: June 20, 2012
Last verified: June 2012
Results First Received: February 29, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Mantle Cell Lymphoma
Intervention: Drug: P276-00

  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
This study was conducted across multiple centers in the United States and India.

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
P276-00 P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity

Participant Flow:   Overall Study
    P276-00  
STARTED     13  
COMPLETED     0  
NOT COMPLETED     13  



  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
P276-00 P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity

Baseline Measures
    P276-00  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     8  
Age  
[units: years]
Mean ± Standard Deviation
  65.8  ± 9.99  
Gender  
[units: participants]
 
Female     4  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     8  
India     5  



  Outcome Measures
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1.  Primary:   Best Overall Objective Response Rate   [ Time Frame: End of every 2 cycles and end of the study treatment ]

2.  Secondary:   Duration of Response   [ Time Frame: End of the study treatment ]

3.  Secondary:   Time to Progression   [ Time Frame: End of study treatment ]


  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
The Sponsor has terminated the study based on interim results. All subjects were off study at the time of termination. There are no major safety or tolerability concerns from this study. The study results published here are preliminary results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Alan Hatfield
Organization: Piramal Healthcare Limited
phone: 02230275000 ext 5002
e-mail: alan.hatfield@piramal.com


No publications provided


Responsible Party: Piramal Enterprises Limited
ClinicalTrials.gov Identifier: NCT00843050     History of Changes
Other Study ID Numbers: P276-00/23/08
Study First Received: February 12, 2009
Results First Received: February 29, 2012
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
India: Drugs Controller General of India