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Trial record 7 of 1216 for:    "Hodgkin lymphoma"

Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01217229
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : March 15, 2013
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Plexxikon

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin Lymphoma
Intervention Drug: PLX3397
Enrollment 20
Recruitment Details Recruitment initiated 12-APR-2011, and study completed 26-APR-2012. Patients recruited from investigator clinics.
Pre-assignment Details  
Arm/Group Title PLX3397
Hide Arm/Group Description PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title PLX3397
Hide Arm/Group Description PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  85.0%
>=65 years
3
  15.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
40.9  (19.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
11
  55.0%
Male
9
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Disease Response Using Cheson Criteria
Hide Description Subjects will be monitored for response and disease progression with contrast CT/18FDG-PET scans every two cycles. Each cycle is 28 days. Response to treatment as defined by Cheson criteria will be reported via descriptive statistics. Per Cheson Criteria: Complete Response (CR) is disappearance of all evidence of disease; Partial Response (PR) is regression of measurable disease and no new sites (≥50% decrease in sum of product diameters of up to 6 largest dominant masses and splenic/liver nodules), and no increase in size of other nodes/liver/spleen; reduction in target lesions, no growth of non-target or new lesions; Progression is any new lesion or increase by ≥50% of previously involved sites from the nadir.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
By protocol
Arm/Group Title PLX3397
Hide Arm/Group Description:
PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Response
1
2.Secondary Outcome
Title Progression Free Survival
Hide Description Subjects will be monitored for disease progression with contrast CT/18FDG-PET scans every two cycles. One cycle is 28 days.
Time Frame 1 Year
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Pharmacodynamic Biomarkers
Hide Description Blood samples for serum CSF-1, IL-34 and biomarkers of Fms inhibiton and Hodgkin Lymphoma activity will be obtained from subjects and analyzed for changes in activity.
Time Frame 1 year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PLX3397
Hide Arm/Group Description PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
All-Cause Mortality
PLX3397
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PLX3397
Affected / at Risk (%)
Total   1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Lung infection   1/20 (5.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PLX3397
Affected / at Risk (%)
Total   20/20 (100.00%) 
Blood and lymphatic system disorders   
Anemia   6/20 (30.00%) 
Thrombocytopenia   6/20 (30.00%) 
General disorders   
Fatigue   8/20 (40.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   5/20 (25.00%) 
Skin and subcutaneous tissue disorders   
Hair depigmentation   8/20 (40.00%) 
Rash   5/20 (25.00%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Name/Title: Medical Monitor
Organization: Plexxikon Inc.
Phone: 510-647-4000
Responsible Party: Plexxikon
ClinicalTrials.gov Identifier: NCT01217229     History of Changes
Other Study ID Numbers: PLX108-03
First Submitted: October 4, 2010
First Posted: October 8, 2010
Results First Submitted: February 12, 2013
Results First Posted: March 15, 2013
Last Update Posted: April 10, 2013