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Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy

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: NCT00377429
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : July 11, 2012
Last Update Posted : July 19, 2012
Sponsor:
Collaborator:
Fresenius Biotech North America
Information provided by (Responsible Party):
Neovii Biotech

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: catumaxomab
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Catumaxomab
Hide Arm/Group Description 4 dose series (10-20-50-150 micrograms) within 21 days
Period Title: Overall Study
Started 47 [1]
Completed 32 [2]
Not Completed 15
Reason Not Completed
Withdrawal by Subject             5
Adverse Event             8
Physician Decision             1
Patient non-compliance             1
[1]
Treated
[2]
Completed main study
Arm/Group Title Catumaxomab
Hide Arm/Group Description 4 dose series (10-20-50-150 micrograms) within 21 days
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
<=18 years
0
   0.0%
Between 18 and 65 years
40
  85.1%
>=65 years
7
  14.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
56.6  (9.36)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
47
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants
47
1.Primary Outcome
Title Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days
Hide Description [Not Specified]
Time Frame 21 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated population
Arm/Group Title Catumaxomab
Hide Arm/Group Description:
4 dose series (10-20-50-150 micrograms) within 21 days
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: Participants
29
2.Secondary Outcome
Title Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy
Hide Description Humoral immune response of participants with functional immune system to catumaxomab can provide important information regarding why a therapy may work for some participants and not for others. An undetectable humoral response by itself does not necessarily imply lack of study drug activity. Humoral response is one of the possible selected measurements of the study drug activity at a time point in the study.
Time Frame 2 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis population
Arm/Group Title Catumaxomab
Hide Arm/Group Description:
4 dose series (10-20-50-150 micrograms) within 21 days
Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Participants
41
3.Secondary Outcome
Title Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)
Hide Description [Not Specified]
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
2nd look laparoscopy/laparotomy
Arm/Group Title Catumaxomab
Hide Arm/Group Description:
4 dose series (10-20-50-150 micrograms) within 21 days
Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: Participants
7
4.Secondary Outcome
Title Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)
Hide Description [Not Specified]
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post study full analysis set
Arm/Group Title Catumaxomab
Hide Arm/Group Description:
4 dose series (10-20-50-150 micrograms) within 21 days
Overall Number of Participants Analyzed 43
Median (Full Range)
Unit of Measure: weeks
86.1
(21.3 to 141.0)
5.Secondary Outcome
Title Number of Participants Who Survived (Post-study at 24 Month Visit)
Hide Description Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Post study full analysis set
Arm/Group Title Catumaxomab
Hide Arm/Group Description:
4 dose series (10-20-50-150 micrograms) within 21 days
Overall Number of Participants Analyzed 43
Measure Type: Number
Unit of Measure: participants
39
6.Secondary Outcome
Title Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)
Hide Description [Not Specified]
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.
Arm/Group Title Catumaxomab
Hide Arm/Group Description:
4 dose series (10-20-50-150 micrograms) within 21 days
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: participants
0
Time Frame End of main study: 90 days after the last dose of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Catumaxomab
Hide Arm/Group Description 4 dose series (10-20-50-150 micrograms) within 21 days
All-Cause Mortality
Catumaxomab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Catumaxomab
Affected / at Risk (%) # Events
Total   19/47 (40.43%)    
Blood and lymphatic system disorders   
Thrombocytopenia  1/47 (2.13%)  1
Gastrointestinal disorders   
Abdominal pain  3/47 (6.38%)  3
Diarrhoea  4/47 (8.51%)  5
Gastrointestinal haemorrhage  1/47 (2.13%)  1
Ileus  1/47 (2.13%)  1
Nausea  8/47 (17.02%)  8
Peritonitis  1/47 (2.13%)  1
Retching  1/47 (2.13%)  1
Small intestinal obstruction  2/47 (4.26%)  2
Volvulus  1/47 (2.13%)  1
Vomiting  8/47 (17.02%)  8
General disorders   
Asthenia  1/47 (2.13%)  1
Chills  1/47 (2.13%)  1
Pyrexia  4/47 (8.51%)  4
Immune system disorders   
Cytokine release syndrome  5/47 (10.64%)  5
Infections and infestations   
Bacteraemia  1/47 (2.13%)  1
Gastroenteritis  1/47 (2.13%)  1
Herpes oesophagitis  1/47 (2.13%)  1
Investigations   
Alanine aminotransferase increased  2/47 (4.26%)  2
Aspartate aminotransferase increased  2/47 (4.26%)  2
Blood creatinine increased  1/47 (2.13%)  1
Metabolism and nutrition disorders   
Dehydration  2/47 (4.26%)  2
Renal and urinary disorders   
Renal failure acute  2/47 (4.26%)  2
Respiratory, thoracic and mediastinal disorders   
Hypoxia  2/47 (4.26%)  2
Vascular disorders   
Hypotension  4/47 (8.51%)  4
1
Term from vocabulary, MedDRA (8.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Catumaxomab
Affected / at Risk (%) # Events
Total   47/47 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  12/47 (25.53%)  13
Lymphopenia  3/47 (6.38%)  4
Cardiac disorders   
Tachycardia  9/47 (19.15%)  14
Gastrointestinal disorders   
Nausea  38/47 (80.85%)  79
Vomiting  34/47 (72.34%)  61
Abdominal pain  33/47 (70.21%)  59
Diarrhoea  24/47 (51.06%)  45
Abdominal distension  13/47 (27.66%)  16
Constipation  10/47 (21.28%)  13
Abdominal discomfort  5/47 (10.64%)  5
Abdominal pain, upper  4/47 (8.51%)  5
Dyspepsia  4/47 (8.51%)  4
Stomatitis  3/47 (6.38%)  3
General disorders   
Pyrexia  38/47 (80.85%)  68
Fatigue  28/47 (59.57%)  46
Chills  27/47 (57.45%)  45
Asthenia  6/47 (12.77%)  7
Pain  5/47 (10.64%)  7
Chest pain  4/47 (8.51%)  4
Malaise  4/47 (8.51%)  5
Oedema peripheral  4/47 (8.51%)  4
Catheter site pain  3/47 (6.38%)  3
Hepatobiliary disorders   
Hyperbilirubinaemia  3/47 (6.38%)  3
Immune system disorders   
Cytokine release syndrome  5/47 (10.64%)  5
Infections and infestations   
Urinary tract infection  8/47 (17.02%)  8
Investigations   
Alanine aminotransferase increased  11/47 (23.40%)  14
Blood potassium decreased  10/47 (21.28%)  17
Blood creatinine increased  9/47 (19.15%)  9
Aspartate aminotransferase increased  7/47 (14.89%)  8
Gamma-glutamyltransferase increased  7/47 (14.89%)  8
Blood alkaline phosphatase increased  5/47 (10.64%)  5
Blood bilirubin increased  4/47 (8.51%)  7
Metabolism and nutrition disorders   
Decreased appetite  10/47 (21.28%)  12
Anorexia  9/47 (19.15%)  10
Dehydration  9/47 (19.15%)  9
Hypokalaemia  8/47 (17.02%)  13
Hypocalcaemia  4/47 (8.51%)  4
Hypoalbuminaemia  3/47 (6.38%)  3
Hypomagnesaemia  3/47 (6.38%)  3
Musculoskeletal and connective tissue disorders   
Myalgia  13/47 (27.66%)  16
Arthralgia  11/47 (23.40%)  13
Back pain  6/47 (12.77%)  8
Flank pain  3/47 (6.38%)  3
Pain in extremity  3/47 (6.38%)  4
Nervous system disorders   
Headache  7/47 (14.89%)  8
Dizziness  5/47 (10.64%)  6
Restless legs syndrome  3/47 (6.38%)  3
Psychiatric disorders   
Insomnia  6/47 (12.77%)  6
Anxiety  4/47 (8.51%)  6
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  9/47 (19.15%)  10
Hypoxia  3/47 (6.38%)  3
Pleural effusion  3/47 (6.38%)  3
Skin and subcutaneous tissue disorders   
Rash  15/47 (31.91%)  19
Hyperhidrosis  4/47 (8.51%)  4
Pruritus  4/47 (8.51%)  5
Vascular disorders   
Hypotension  10/47 (21.28%)  12
Hypertension  5/47 (10.64%)  14
Flushing  3/47 (6.38%)  3
1
Term from vocabulary, MedDRA (8.0)
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 1st publication of study results shall be a multicenter publication or disclosure coordinated by sponsor.

Prior to submitting for publication, the Investigator shall allow sponsor at least 60 days to review the proposed Publication. Proposed Publications shall not include either Fresenius Biotech confidential information other than the study results or personal data on any patient. If parties disagree, parties will meet to discuss and resolve any disagreements.

Results Point of Contact
Name/Title: Anne Kuan
Organization: Fresenius Biotech
Phone: 781 699 4618
Responsible Party: Neovii Biotech
ClinicalTrials.gov Identifier: NCT00377429     History of Changes
Other Study ID Numbers: IP-CAT-OC-01
First Submitted: September 15, 2006
First Posted: September 18, 2006
Results First Submitted: March 15, 2012
Results First Posted: July 11, 2012
Last Update Posted: July 19, 2012