Trial Outcomes & Findings for Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy (NCT NCT00377429)
NCT ID: NCT00377429
Last Updated: 2012-07-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
21 days
Results posted on
2012-07-19
Participant Flow
Participant milestones
| Measure |
Catumaxomab
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Catumaxomab
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Patient non-compliance
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Catumaxomab to Treat Ovarian Cancer After a Complete Response to Chemotherapy
Baseline characteristics by cohort
| Measure |
Catumaxomab
n=47 Participants
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age Continuous
|
56.6 years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Treated population
Outcome measures
| Measure |
Catumaxomab
n=47 Participants
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Number of Participants Who Completed a 4-dose Series of Catumaxomab Infusions (Defined as 10-20-50-150 Micrograms) Within 21 Days
|
29 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Full analysis population
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.
Outcome measures
| Measure |
Catumaxomab
n=42 Participants
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Number of Participants With Negative (Undetectable) Humoral Immune Responses to Catumaxomab Therapy
|
41 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: 2nd look laparoscopy/laparotomy
Outcome measures
| Measure |
Catumaxomab
n=11 Participants
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Number of Participants With no Residual Disease Prior to Catumaxomab Treatment Via 2nd-look Laparoscopy or Laparotomy (These Procedures Are Optional)
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Post study full analysis set
Outcome measures
| Measure |
Catumaxomab
n=43 Participants
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Median Time of Progression-free Survival in Weeks (Post-study for 24 Months)
|
86.1 weeks
Interval 21.3 to 141.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Post study full analysis set
Number of participants who survived (post-study at 24 month visit) is the number of participants who did not die
Outcome measures
| Measure |
Catumaxomab
n=43 Participants
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Number of Participants Who Survived (Post-study at 24 Month Visit)
|
39 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only 1 patient received 3rd-look laparoscopy/laparotomy as determined by the investigator and no residual disease was found.
Outcome measures
| Measure |
Catumaxomab
n=1 Participants
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Number of Participants With no Residual Disease at 3 Months After Catumaxomab Treatment Via 3rd-look Laparoscopy or Laparotomy (These Procedures Are Optional)
|
0 participants
|
Adverse Events
Catumaxomab
Serious events: 19 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Catumaxomab
n=47 participants at risk
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
4/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Ileus
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
17.0%
8/47 • Number of events 8 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Peritonitis
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Retching
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.3%
2/47 • Number of events 2 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Volvulus
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
17.0%
8/47 • Number of events 8 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Asthenia
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Chills
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Pyrexia
|
8.5%
4/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
Immune system disorders
Cytokine release syndrome
|
10.6%
5/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
Infections and infestations
Bacteraemia
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Infections and infestations
Gastroenteritis
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Infections and infestations
Herpes oesophagitis
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
2/47 • Number of events 2 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
2/47 • Number of events 2 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Blood creatinine increased
|
2.1%
1/47 • Number of events 1 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
2/47 • Number of events 2 • End of main study: 90 days after the last dose of study drug
|
|
Renal and urinary disorders
Renal failure acute
|
4.3%
2/47 • Number of events 2 • End of main study: 90 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.3%
2/47 • Number of events 2 • End of main study: 90 days after the last dose of study drug
|
|
Vascular disorders
Hypotension
|
8.5%
4/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
Other adverse events
| Measure |
Catumaxomab
n=47 participants at risk
4 dose series (10-20-50-150 micrograms) within 21 days
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.5%
12/47 • Number of events 13 • End of main study: 90 days after the last dose of study drug
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.4%
3/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
Cardiac disorders
Tachycardia
|
19.1%
9/47 • Number of events 14 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Nausea
|
80.9%
38/47 • Number of events 79 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Vomiting
|
72.3%
34/47 • Number of events 61 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
70.2%
33/47 • Number of events 59 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
51.1%
24/47 • Number of events 45 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal distension
|
27.7%
13/47 • Number of events 16 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Constipation
|
21.3%
10/47 • Number of events 13 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.6%
5/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Abdominal pain, upper
|
8.5%
4/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
8.5%
4/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
Gastrointestinal disorders
Stomatitis
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Pyrexia
|
80.9%
38/47 • Number of events 68 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Fatigue
|
59.6%
28/47 • Number of events 46 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Chills
|
57.4%
27/47 • Number of events 45 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Asthenia
|
12.8%
6/47 • Number of events 7 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Pain
|
10.6%
5/47 • Number of events 7 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Chest pain
|
8.5%
4/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Malaise
|
8.5%
4/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Oedema peripheral
|
8.5%
4/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
General disorders
Catheter site pain
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Immune system disorders
Cytokine release syndrome
|
10.6%
5/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
Infections and infestations
Urinary tract infection
|
17.0%
8/47 • Number of events 8 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Alanine aminotransferase increased
|
23.4%
11/47 • Number of events 14 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Blood potassium decreased
|
21.3%
10/47 • Number of events 17 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Blood creatinine increased
|
19.1%
9/47 • Number of events 9 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Aspartate aminotransferase increased
|
14.9%
7/47 • Number of events 8 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.9%
7/47 • Number of events 8 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Blood alkaline phosphatase increased
|
10.6%
5/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
Investigations
Blood bilirubin increased
|
8.5%
4/47 • Number of events 7 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.3%
10/47 • Number of events 12 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Anorexia
|
19.1%
9/47 • Number of events 10 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
19.1%
9/47 • Number of events 9 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.0%
8/47 • Number of events 13 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.5%
4/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.7%
13/47 • Number of events 16 • End of main study: 90 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.4%
11/47 • Number of events 13 • End of main study: 90 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
6/47 • Number of events 8 • End of main study: 90 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
3/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
Nervous system disorders
Headache
|
14.9%
7/47 • Number of events 8 • End of main study: 90 days after the last dose of study drug
|
|
Nervous system disorders
Dizziness
|
10.6%
5/47 • Number of events 6 • End of main study: 90 days after the last dose of study drug
|
|
Nervous system disorders
Restless legs syndrome
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Psychiatric disorders
Insomnia
|
12.8%
6/47 • Number of events 6 • End of main study: 90 days after the last dose of study drug
|
|
Psychiatric disorders
Anxiety
|
8.5%
4/47 • Number of events 6 • End of main study: 90 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.1%
9/47 • Number of events 10 • End of main study: 90 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
31.9%
15/47 • Number of events 19 • End of main study: 90 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.5%
4/47 • Number of events 4 • End of main study: 90 days after the last dose of study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.5%
4/47 • Number of events 5 • End of main study: 90 days after the last dose of study drug
|
|
Vascular disorders
Hypotension
|
21.3%
10/47 • Number of events 12 • End of main study: 90 days after the last dose of study drug
|
|
Vascular disorders
Hypertension
|
10.6%
5/47 • Number of events 14 • End of main study: 90 days after the last dose of study drug
|
|
Vascular disorders
Flushing
|
6.4%
3/47 • Number of events 3 • End of main study: 90 days after the last dose of study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER