Trial Outcomes & Findings for Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer (NCT NCT00072410)
NCT ID: NCT00072410
Last Updated: 2023-10-04
Results Overview
All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT was defined as: * Any Grade 3 or greater non-hematological toxicity (except for alopecia, nausea, and vomiting, defined separately below) * Any Grade alopecia * Grade 4 nausea or vomiting ≥ 5 days duration. * Any Grade 4 hematological toxicity (except for toxicity of ≤ 5 days duration without growth factor, platelet, or transfusion support). To be dose limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
7 participants
Primary outcome timeframe
Up to day 56
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
Cohort 1
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Cohort 2
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Cohort 2
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
|---|---|---|
|
Overall Study
Progressive disease
|
0
|
3
|
Baseline Characteristics
Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Cohort 2
n=4 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to day 56Population: All patients who entered the study.
All adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT was defined as: * Any Grade 3 or greater non-hematological toxicity (except for alopecia, nausea, and vomiting, defined separately below) * Any Grade alopecia * Grade 4 nausea or vomiting ≥ 5 days duration. * Any Grade 4 hematological toxicity (except for toxicity of ≤ 5 days duration without growth factor, platelet, or transfusion support). To be dose limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Cohort 2
n=4 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
|---|---|---|
|
Number of Patients With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 22 daysPopulation: All patients who entered the study and had serum samples taken at the specified times. Patient No. 5 in Cohort 2 did not have Day 22 blood drawn and was not included in the mean value.
Serum samples were taken 5 min, 1 hour, and 2 hours after end of infusion, twice on study day 2, and daily on study days 3 to 7, 8, 15 and 22. Serum samples were analyzed in a gamma well counter. Elimination half-life (T1/2) was generated by fitting effective clearance to a monoexponential curve.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Cohort 2
n=3 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
|---|---|---|
|
Clearance as Measured by the Half-life (T1/2) of the Elimination Phase
|
2.43 days
Interval 2.31 to 2.57
|
2.28 days
Interval 2.22 to 2.34
|
SECONDARY outcome
Timeframe: Up to day 56Population: All patients who entered the study.
Blood samples were taken at baseline and on days15, 28 and 56. HAHA was measured by BIACORE.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Cohort 2
n=4 Participants
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
|---|---|---|
|
Number of Patients With Human Anti-human Antibodies (HAHA) After Treatment
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 10 millicuries (mCi) 90Y and 5 mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
Cohort 2
n=4 participants at risk
Patients received a single intraperitoneal (IP) dose of 10 mg of hu3S193 radiolabeled with 15 millicuries (mCi) 90Y and 5mCi 111In-hu3S193 to enable imaging after dosing.
90Y-hu3S193: Patients received a single dose of 10 mg of hu3S193 radiolabeled with the intended dose (mCi) of 90Y.
111In-hu3S193: Patients received a single dose of 5 mCi 111In-hu3S193 together with the 90Y-hu3S193.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
33.3%
1/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
0.00%
0/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
25.0%
1/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Reproductive system and breast disorders
Pelvic pain
|
33.3%
1/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
0.00%
0/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Cardiac disorders
Dizziness
|
33.3%
1/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
0.00%
0/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
General disorders
Fatigue
|
33.3%
1/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
0.00%
0/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
33.3%
1/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
0.00%
0/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
0.00%
0/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
25.0%
1/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
25.0%
1/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
25.0%
1/4 • up to 56 days
All adverse events occurring during the study were recorded on the patient's case report form. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999).
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place