Trial Outcomes & Findings for Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors (NCT NCT02609737)
NCT ID: NCT02609737
Last Updated: 2022-02-01
Results Overview
according to RECIST 1.1 and median progression-free and overall survival will be estimated and reported with 95% confidence intervals
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
2 years
Results posted on
2022-02-01
Participant Flow
Participant milestones
| Measure |
68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Theranostics of Radiolabeled Somatostatin Antagonists 68Ga-DOTA-JR11 and 177Lu-DOTA-JR11 in Patients With Neuroendocrine Tumors
Baseline characteristics by cohort
| Measure |
68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
n=20 Participants
Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 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
|
1 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsaccording to RECIST 1.1 and median progression-free and overall survival will be estimated and reported with 95% confidence intervals
Outcome measures
| Measure |
68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
n=20 Participants
Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
|
|---|---|
|
Overall Response Rate (ORR)
Complete Response
|
1 Participants
|
|
Overall Response Rate (ORR)
Partial Response
|
8 Participants
|
|
Overall Response Rate (ORR)
Stable Disease
|
8 Participants
|
|
Overall Response Rate (ORR)
Progression of Disease
|
3 Participants
|
Adverse Events
68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
Serious events: 7 serious events
Other events: 13 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
n=20 participants at risk
Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • 1 year
|
|
Gastrointestinal disorders
Esophageal varices hemorrhage
|
10.0%
2/20 • 1 year
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.0%
1/20 • 1 year
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
25.0%
5/20 • 1 year
|
|
Investigations
Neutrophil count decreased
|
15.0%
3/20 • 1 year
|
|
Investigations
Platelet count decreased
|
30.0%
6/20 • 1 year
|
|
Investigations
White blood cell decreased
|
15.0%
3/20 • 1 year
|
Other adverse events
| Measure |
68Ga-DOTA-JR11 and 177Lu-DOTA-JR11
n=20 participants at risk
Pts get a PET/CT study with approx.150-200 MBq of 68Ga-DOTA-JR11. Lesions with focal radiotracer uptake not explained by physiologic sstr2 expression will be interpreted as metastatic disease. If 68Ga-DOTA-JR11 uptake by metastases with a diameter of more than 2 cm is less than the physiologic radiotracer uptake by the liver, no further imaging \& therapy will be performed as part of the study, as it is unlikely that pts with this low radiotracer uptake will benefit from PRRT (2). All other pts will undergo a dosimetric study with 1850 MBq (less than 100 μg peptide) of 177Lu-DOTA-JR11. Results of the dosimetry study, will determine the balance of activity of 177Lu-DOTA-JR11 that can be administered without exceeding the radiation dose limits. This activity will be split into 2 equal amounts to be delivered in 2 cycles, approximately 3 months apart. After each therapy cycle, pts will be followed clinically for 3 months.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
2/20 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
1/20 • 1 year
|
|
General disorders
Edema (face)
|
5.0%
1/20 • 1 year
|
|
General disorders
Edema (limbs)
|
10.0%
2/20 • 1 year
|
|
Gastrointestinal disorders
Mucositis (oral)
|
5.0%
1/20 • 1 year
|
|
Nervous system disorders
Asthenia
|
5.0%
1/20 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • 1 year
|
|
Nervous system disorders
Tremor
|
5.0%
1/20 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • 1 year
|
Additional Information
Dr. Lisa Bodie, MD, PhD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-6650
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place