Trial Outcomes & Findings for Phase II Study of Clinical Activity of Pegaspargase in Women With Relapsed or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer (NCT NCT01313078)
NCT ID: NCT01313078
Last Updated: 2015-10-09
Results Overview
Proportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as \>20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
6 months
Results posted on
2015-10-09
Participant Flow
Participant milestones
| Measure |
Pegaspargase in Women With Cancer
Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Pegaspargase in Women With Cancer
Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Discontinued study drug
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Study of Clinical Activity of Pegaspargase in Women With Relapsed or Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and/or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Pegaspargase in Women With Cancer
n=4 Participants
Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProportion of patients able to attain a 6 month progression free survival. Progressive disease is defined as \>20% increase in the sum of the longest diameter of all target lesions, or the unequivocal increase in size of non-measurable lesions agreed upon by two investigators, or the appearance of new lesions.
Outcome measures
| Measure |
Pegaspargase in Women With Cancer
n=4 Participants
Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
|
|---|---|
|
6 Month Progression Free Survival
|
0 Participants
|
PRIMARY outcome
Timeframe: 11 months, 25 daysHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Pegaspargase in Women With Cancer
n=4 Participants
Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
|
|---|---|
|
Evaluation of Safety in Patients With Ovarian, Fallopian Tube, and/or Primary Peritoneal Cancer.
|
4 Participants
|
Adverse Events
Pegaspargase in Women With Cancer
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegaspargase in Women With Cancer
n=4 participants at risk
Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
|
|---|---|
|
Immune system disorders
Allergic reaction
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Pegaspargase in Women With Cancer
n=4 participants at risk
Pegaspargase 2000 IU/m\^2 intramuscular or intravenously every 2 weeks
|
|---|---|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Activated partial thromboplastin time prolonged
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
2/4 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
2/4 • Number of events 2
|
|
Gastrointestinal disorders
Bloating
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Blood bilirubin increased
|
50.0%
2/4 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Fibrinogen decreased
|
50.0%
2/4 • Number of events 4
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify (Urgency bowel movement)
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
2/4 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
25.0%
1/4 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Investigations-Other, specify (PT, high)
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Lipase increased
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Tremor
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1
|
|
Investigations
Weight loss
|
25.0%
1/4 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1
|
Additional Information
Elise Kohn, M.D.
National Cancer Institute, National Institutes of Health
Phone: 301-496-9336
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place