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A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytokinetics
ClinicalTrials.gov Identifier:
NCT00343564
First received: June 21, 2006
Last updated: August 8, 2016
Last verified: August 2016
Results First Received: August 8, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Non-Hodgkin's Lymphoma
Hodgkin's Disease
Intervention: Drug: SB-743921

  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
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
2 mg/m2 Without GCSF Phase 1 dose escalation cohort 1 without GCSF support
3 mg/m2 Without GCSF Phase 1 dose escalation cohort 2 without GCSF support
4 mg/m2 Without GCSF Phase 1 dose escalation cohort 3 without GCSF support
5 mg/m2 Without GCSF Phase 1 dose escalation cohort 4 without GCSF support
6 mg/m2 Without GCSF Phase 1 dose escalation cohort 5 without GCSF support
7 mg/m2 Without GCSF Phase 1 dose escalation cohort 6 without GCSF support
6 mg/m2 With GCSF Phase 1 dose escalation cohort 1 with GCSF support
7 mg/m2 With GCSF Phase 1 dose escalation cohort 2 with GCSF support
8 mg/m2 With GCSF Phase 1 dose escalation cohort 3 with GCSF support
9 mg/m2 With GCSF Phase 1 dose escalation cohort 4 with GCSF support
10 mg/m2 With GCSF Phase 1 dose escalation cohort 5 with GCSF support

Participant Flow:   Overall Study
    2 mg/m2 Without GCSF   3 mg/m2 Without GCSF   4 mg/m2 Without GCSF   5 mg/m2 Without GCSF   6 mg/m2 Without GCSF   7 mg/m2 Without GCSF   6 mg/m2 With GCSF   7 mg/m2 With GCSF   8 mg/m2 With GCSF   9 mg/m2 With GCSF   10 mg/m2 With GCSF
STARTED   6   7   3   7   10   9   4   3   3   8   8 
COMPLETED   6   7   3   7   10   9   4   3   3   8   8 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   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.
No text entered.

Reporting Groups
  Description
2 mg/m2 Without GCSF Phase 1 dose escalation cohort 1 without GCSF support
3 mg/m2 Without GCSF Phase 1 dose escalation cohort 2 without GCSF support
4 mg/m2 Without GCSF Phase 1 dose escalation cohort 3 without GCSF support
5 mg/m2 Without GCSF Phase 1 dose escalation cohort 4 without GCSF support
6 mg/m2 Without GCSF Phase 1 dose escalation cohort 5 without GCSF support
7 mg/m2 Without GCSF Phase 1 dose escalation cohort 6 without GCSF support
6 mg/m2 With GCSF Phase 1 dose escalation cohort 1 with GCSF support
7 mg/m2 With GCSF Phase 1 dose escalation cohort 2 with GCSF support
8 mg/m2 With GCSF Phase 1 dose escalation cohort 3 with GCSF support
9 mg/m2 With GCSF Phase 1 dose escalation cohort 4 with GCSF support
10 mg/m2 With GCSF Phase 1 dose escalation cohort 5 with GCSF support
Total Total of all reporting groups

Baseline Measures
   2 mg/m2 Without GCSF   3 mg/m2 Without GCSF   4 mg/m2 Without GCSF   5 mg/m2 Without GCSF   6 mg/m2 Without GCSF   7 mg/m2 Without GCSF   6 mg/m2 With GCSF   7 mg/m2 With GCSF   8 mg/m2 With GCSF   9 mg/m2 With GCSF   10 mg/m2 With GCSF   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   7   3   7   10   9   4   3   3   8   8   68 
Age 
[Units: Participants]
                       
<=18 years   0   0   0   0   0   1   0   0   0   0   0   1 
Between 18 and 65 years   4   7   3   3   8   6   1   2   1   4   4   43 
>=65 years   2   0   0   4   2   2   3   1   2   4   4   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (9)   43  (13)   33  (9)   57  (22)   48  (16)   42  (24)   69  (12)   63  (11)   63  (17)   48  (22)   56  (20)   52  (19) 
Gender 
[Units: Participants]
                       
Female   4   6   1   2   4   4   2   1   1   3   1   29 
Male   2   1   2   5   6   5   2   2   2   5   7   39 
Region of Enrollment 
[Units: Participants]
                       
United States   6   4   1   5   7   6   4   3   2   8   7   53 
Russian Federation   0   3   2   2   3   3   0   0   1   0   1   15 


  Outcome Measures

1.  Primary:   Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.   [ Time Frame: 28 days ]

2.  Secondary:   Phase 1: Pharmacokinetics of SB-743921 Administered on a Days 1 and 15 of a 28 Day Cycle.   [ Time Frame: 28 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Project Manager
Organization: Cytokinetics,Inc.
phone: 650-624-2918


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

Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT00343564     History of Changes
Other Study ID Numbers: CY 2121
Study First Received: June 21, 2006
Results First Received: August 8, 2016
Last Updated: August 8, 2016
Health Authority: United States: Food and Drug Administration
Russia: Pharmacological Committee, Ministry of Health