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Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)

This study has been terminated.
(The study was terminated for business reasons.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01370694
First received: May 18, 2011
Last updated: April 25, 2016
Last verified: April 2016
Results First Received: October 23, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Follicular Lymphoma
Interventions: Drug: MK-8808
Drug: cyclophosphamide
Drug: vincristine
Drug: prednisolone

  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
The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 on 18 March 2014, but could continue to receive maintenance therapy with rituximab per standard of care.

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
MK-8808 Combination Therapy Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.

Participant Flow:   Overall Study
    MK-8808 Combination Therapy
STARTED   7 
COMPLETED   1 
NOT COMPLETED   6 
Switched to rituximab                4 
Progressive disease                2 



  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
MK-8808 Combination Therapy Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.

Baseline Measures
   MK-8808 Combination Therapy 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.1  (16.4) 
Gender 
[Units: Participants]
 
Female   2 
Male   5 


  Outcome Measures
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1.  Primary:   Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy   [ Time Frame: From first dose of combination therapy up to 24 weeks ]

2.  Primary:   Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy   [ Time Frame: From first dose of single agent MK-8808 up to 2 years ]

3.  Secondary:   Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP   [ Time Frame: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks) ]

4.  Secondary:   Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy   [ Time Frame: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years) ]

5.  Secondary:   Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP   [ Time Frame: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks) ]

6.  Secondary:   Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance   [ Time Frame: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years) ]

7.  Secondary:   Clinical Response of Tumor to MK-8808/CVP Combination Therapy   [ Time Frame: Up to 2 years ]


  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 study was terminated for business reasons. Not all planned analyses were performed


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01370694     History of Changes
Other Study ID Numbers: 8808-001
2011-000386-13 ( EudraCT Number )
Study First Received: May 18, 2011
Results First Received: October 23, 2015
Last Updated: April 25, 2016
Health Authority: Russia: Ministry of Health of the Russian Federation