Trial Outcomes & Findings for Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer (NCT NCT01774071)
NCT ID: NCT01774071
Last Updated: 2024-10-02
Results Overview
Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
2 years
Results posted on
2024-10-02
Participant Flow
Participant milestones
| Measure |
89Zr DFOMSTP2109A Tracer Group 1 - 10mg
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan.
|
89Zr-DFO-MSTP2109A Tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection).
No research blood work will be drawn in Group 2
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
0
|
|
Overall Study
COMPLETED
|
19
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of 89Zr-DFO-MSTP2109A in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
89Zr DFOMSTP2109A Tracer Group 1
n=19 Participants
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan.
|
89Zr-DFO-MSTP2109A Tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection).
No research blood work will be drawn in Group 2
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
—
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
—
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
—
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
—
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
—
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants not enrolled into Group 2
Antibody imaging will be considered feasible if 75% of the patients are antibody-imaging-positive. We will enroll 6 patients (cohort 1A) at the 10mg dose level for an initial decision on feasibility. If 4 or more of these patients have 20% or more of their active lesions detectable by 89Zr-DFO-MSTP2109A then we will consider the agent feasible for imaging, otherwise we will proceed to cohort 1B. If the true feasibility rate is 40%, this rule will affords more than 82% chance that cohort 1B will be opened for enrollment; this probability is less than 17% if the true feasibility is 75%.
Outcome measures
| Measure |
89Zr DFOMSTP2109A Tracer Group 1
n=19 Participants
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan.
|
89Zr-DFO-MSTP2109A Tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection).
No research blood work will be drawn in Group 2
|
|---|---|---|
|
Percentage of Participants With Histologically Positive Lesions That Are Positive on Imaging
|
86 % of participants with + lesions
Interval 75.0 to 100.0
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants not enrolled into Group 2
All participants will be evaluated for adverse events which will be graded for intensity on a scale of 0 to 5. Severity grades will be recorded and based on the CTCAE v4.0. Adverse events will be defined graded using CTCAE V4.0.
Outcome measures
| Measure |
89Zr DFOMSTP2109A Tracer Group 1
n=19 Participants
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan.
|
89Zr-DFO-MSTP2109A Tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection).
No research blood work will be drawn in Group 2
|
|---|---|---|
|
Number of Participants Evaluated for AEs
|
19 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 168 hoursPopulation: Participants not enrolled to Group 2
Serial blood draws will be used to estimate the pharmacokinetic profile of the 10mg 89Zr-DFO-MSTP2109A in this patient population. Blood samples will be obtained in green top tube: Just prior to injection of 89Zr-DFO-MSTP2109A (baseline)Approximately 5 ± 2, 15 ± 5, 30 ± 9, 60 ± 19, and 120 to 240 minutes after injection of the tracer. One sample at the time of each subsequent day of imaging (24 + 8h, \~48-96h and \~120-168h post injection).
Outcome measures
| Measure |
89Zr DFOMSTP2109A Tracer Group 1
n=19 Participants
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan.
|
89Zr-DFO-MSTP2109A Tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection).
No research blood work will be drawn in Group 2
|
|---|---|---|
|
Rate of Clearance of Tracer 89Zr-DFO-MSTP2109A
|
19.7 mL/hour
Interval 0.64 to 79.7
|
—
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Participants not enrolled to Group 2
A PET-CT scan extending from top of skull to mid thighs will be performed to determine the biodistribution/SUVmax in bone and soft tissue
Outcome measures
| Measure |
89Zr DFOMSTP2109A Tracer Group 1
n=19 Participants
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan.
|
89Zr-DFO-MSTP2109A Tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection).
No research blood work will be drawn in Group 2
|
|---|---|---|
|
Biodistribution/SUVmax
SUVmax in bone
|
20.6 g/mL
Interval 4.4 to 59.3
|
—
|
|
Biodistribution/SUVmax
SUVmax in soft tissue
|
16.8 g/mL
Interval 9.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants not enrolled in Group 2
Ability of 89Zr-DFO-MSTP2109A PET to detect sites of metastatic prostate cancer.
Outcome measures
| Measure |
89Zr DFOMSTP2109A Tracer Group 1
n=17 lesions
The first group of participants will include 6 participants whom will receive 10mg of 89Zr-DFO-MSTP2109A. A second group of 6 participants may receive twice the amount of antibody to determine if this results in better pictures of your tumors. Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2.
89Zr- DFO-MSTP2109A: If you are enrolled onto Group 1:
Once you are given the diagnostic agent, the following procedures will be done:
PET scans at the approximate times:
* 1-4 hours after the injection
* 24 hours after the injection (the next day, Day 2)
* 48-120 hours after the injection (on either Day 3, 4, or 5)
* 144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
* Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
* At each time of your scheduled PET scan.
|
89Zr-DFO-MSTP2109A Tracer Group 2
Once we determine whether 10 mg or the larger 20 mg dose of 89Zr-DFOMSTP2109A is best and well tolerated we will use that amount for future participants in Group 2. Group 2 will include up to 15 participants whom may receive a dose of up to 20mg.
89Zr DFO-MSTP2109A: If you are enrolled onto Group 2:
Once you are given the study drug, the following procedures will be done:
You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (\~ 3-7 days after injection).
No research blood work will be drawn in Group 2
|
|---|---|---|
|
Percentage of Histologically Positive Lesions That Were True Positive on PET Imaging
|
86 % of positive lesions
Interval 75.0 to 100.0
|
—
|
Adverse Events
89Zr DFOMSTP2109A Tracer Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
89Zr-DFO-MSTP2109A Tracer Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Steven Larson, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-2212
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place