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A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517530
First received: August 16, 2007
Last updated: August 18, 2016
Last verified: August 2016
Results First Received: July 14, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Drug: Obinutuzumab

  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
Different patients were recruited into Phase I and Phase II, and analyzed separately based on their disease. In this adaptive trial design, some of those same patients were included in follow-up even if they did not complete treatment, and 13 who had initially responded to treatment but subsequently progressed were retreated.

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
50-2000 mg Phase I, NHL Obinutuzumab intravenous infusion
400-2000 mg Phase I, CLL Obinutuzumab intravenous infusion
400/400 mg - Phase II, iNHL Obinutuzumab intravenous infusion
1600/800 mg - Phase II, iNHL Obinutuzumab intravenous infusion
400/400 mg - Phase II, aNHL Obinutuzumab intravenous infusion
1600/800 mg - Phase II, aNHL Obinutuzumab intravenous infusion
1000/1000 mg - Phase II, CLL Obinutuzumab intravenous infusion

Participant Flow:   Overall Study
    50-2000 mg Phase I, NHL   400-2000 mg Phase I, CLL   400/400 mg - Phase II, iNHL   1600/800 mg - Phase II, iNHL   400/400 mg - Phase II, aNHL   1600/800 mg - Phase II, aNHL   1000/1000 mg - Phase II, CLL
STARTED   21   13   18   22   21   19   20 
Completed Treatment   11   13   13   18   9   9   13 
Started Follow-up   20   13   17   21   17   16   19 
Completed Follow-up   2   0   0   1   0   0   1 
Retreated Population   2   2   1   4   2   2   0 
COMPLETED   2   0   0   1   1   0   1 
NOT COMPLETED   19   13   18   21   20   19   19 



  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.
Safety population: All enrolled participants who had received at least 1 dose of obinutuzumab.

Reporting Groups
  Description
50-2000 mg Phase I, NHL Obinutuzumab intravenous infusion
400-2000 mg Phase I, CLL Obinutuzumab intravenous infusion
400/400 mg - Phase II, iNHL Obinutuzumab intravenous infusion
1600/800 mg - Phase II, iNHL Obinutuzumab intravenous infusion
400/400 mg - Phase II, aNHL Obinutuzumab intravenous infusion
1600/800 mg - Phase II, aNHL Obinutuzumab intravenous infusion
1000/1000 mg - Phase II, CLL Obinutuzumab intravenous infusion
Total Total of all reporting groups

Baseline Measures
   50-2000 mg Phase I, NHL   400-2000 mg Phase I, CLL   400/400 mg - Phase II, iNHL   1600/800 mg - Phase II, iNHL   400/400 mg - Phase II, aNHL   1600/800 mg - Phase II, aNHL   1000/1000 mg - Phase II, CLL   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   13   18   22   21   19   20   134 
Age 
[Units: Participants]
               
<=18 years   0   0   0   0   0   0   0   0 
Between 18 and 65 years   11   7   14   14   6   7   11   70 
>=65 years   10   6   4   8   15   12   9   64 
Gender 
[Units: Participants]
               
Female   12   4   6   9   8   5   8   52 
Male   9   9   12   13   13   14   12   82 


  Outcome Measures
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1.  Primary:   Percentage of Participants Who Experienced a Dose-limiting Toxicity in Phase I of the Study   [ Time Frame: Baseline to 28 days after the last infusion of obinutuzumab (up to 6 months) ]

2.  Primary:   Percentage of Participants With Best Overall Response in Phase II of the Study   [ Time Frame: by Cutoff Date: 31 March 2012 (within 3 years, 4 months) ]

3.  Secondary:   Percentage of Participants With Complete Response (CR/CRu/CRi) in Phase II of the Study   [ Time Frame: by Cutoff Date: 31 March 2012 (within 3 years, 4 months) ]

4.  Secondary:   Percentage of Participants With Partial Response (PR) in Phase II of the Study   [ Time Frame: by Cutoff Date: 31 March 2012 (within 3 years, 4 months) ]

5.  Secondary:   Progression-free Survival (PFS) in Phase II of the Study   [ Time Frame: by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) ]

6.  Secondary:   Duration of Response by Disease Type in Phase II of the Study   [ Time Frame: by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) ]

7.  Secondary:   Participants With Event-Free Survival (EFS) in Phase II of the Study   [ Time Frame: by the end of the follow-up period in Phase II of the study (within 3 years, 4 months) ]

8.  Secondary:   Pharmacodynamics: Participants With Peripheral B-cell Recovery After Having Had Depletion at End of Treatment During Phase II of the Study   [ Time Frame: by the end of Phase II (within 3 years, 4 months) ]

9.  Secondary:   Percentage of Retreated Participants With Response   [ Time Frame: by Cutoff Date: 25 November 2013 (within 4 years, 2 months) ]

10.  Secondary:   Maximum Plasma Concentration (Cmax) of Obinutuzumab in NHL Participants   [ Time Frame: at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days) ]

11.  Secondary:   Area Under the Concentration-time Curve of Obinutuzumab Administered on Day 1 of Cycle 1 in Phase I of the Study   [ Time Frame: Day 1 of Cycle 1 ]

12.  Other Pre-specified:   Maximum Plasma Concentration (Cmax) of Obinutuzumab in CLL Patients   [ Time Frame: at Cycle 1 Day 1, Cycle 1 Day 8 and Cycle 8 (over 168 days) ]


  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
Pharmacodynamic results were limited because number of participants was inversely proportional to length of follow-up. In other words, there were fewer participants still in the trial as the follow-up period became longer.


  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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800 821-8590
e-mail: genentech@druginfo.com


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


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517530     History of Changes
Other Study ID Numbers: BO20999
2007-001103-37 ( EudraCT Number )
Study First Received: August 16, 2007
Results First Received: July 14, 2015
Last Updated: August 18, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut