Trial Outcomes & Findings for PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer (NCT NCT02023996)
NCT ID: NCT02023996
Last Updated: 2024-12-10
Results Overview
Participants will be evaluated for toxicity using CTCAE v4.0
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
2 years
Results posted on
2024-12-10
Participant Flow
This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
Participant milestones
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
89Zr-DFO-trastuzumab
PET imaging
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
89Zr-DFO-trastuzumab
PET imaging
|
|---|---|
|
Overall Study
Protocol Violation
|
6
|
Baseline Characteristics
PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer
Baseline characteristics by cohort
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
n=36 Participants
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
89Zr-DFO-trastuzumab
PET imaging
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
Participants will be evaluated for toxicity using CTCAE v4.0
Outcome measures
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
n=36 Participants
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
89Zr-DFO-trastuzumab
PET imaging
|
|---|---|
|
Safety as Measured by the Number of Participants Who Experienced Toxicity
Participants with toxicity
|
2 Participants
|
|
Safety as Measured by the Number of Participants Who Experienced Toxicity
Participants without toxicity
|
34 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
Antibody imaging is considered feasible if 70% of the patients are antibody-imaging positive. Antibody imaging will be considered feasible if 7 or more of the 10 patients in the first cohort are antibody-imaging-positive. We will also require that none of these patients experience severe toxicity attributable to the initial antibody.
Outcome measures
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
n=36 Participants
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
89Zr-DFO-trastuzumab
PET imaging
|
|---|---|
|
Feasibility of Antibody-imaging
Participants with >/= 50% tumor load positivity
|
24 Participants
|
|
Feasibility of Antibody-imaging
Participants with <50% tumor load positivity
|
12 Participants
|
SECONDARY outcome
Timeframe: Up to 580 hoursPopulation: This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
Samples will be obtained just prior to injection of the 89Zr DFO-trastuzumab tracer this sample will be banked at -80degree C for future testing for Human anti-human antibody/HAHA if altered biodistribution is observed.
Outcome measures
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
n=36 Participants
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
89Zr-DFO-trastuzumab
PET imaging
|
|---|---|
|
Biologic Half-time
|
370 hours
Interval 257.0 to 578.0
|
Adverse Events
PET Imaging With 89Zr-DFO-Trastuzumab
Serious events: 2 serious events
Other events: 2 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
n=36 participants at risk
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
1/36 • 2 years
|
|
General disorders
Non-cardiac chest pain
|
2.8%
1/36 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • 2 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
2.8%
1/36 • 2 years
|
Other adverse events
| Measure |
PET Imaging With 89Zr-DFO-Trastuzumab
n=36 participants at risk
Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.
This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
|
|---|---|
|
General disorders
Chills
|
2.8%
1/36 • 2 years
|
|
General disorders
Fever
|
2.8%
1/36 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.8%
1/36 • 2 years
|
Additional Information
Dr. Neeta Pandit-Taskar, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3046
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place