Frequency of Tumor Response at 9 Months After Last Treatment
| Group | Value (Participants) |
|---|---|
| 90Y-DOTA-tyr3-Octreotide | 0 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
NCT0327371229 Sept 2017 to 27 May 2020
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors.
Experimental
90Y-DOTA-tyr3-Octreotide
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
Outcomes the sponsor listed as primary.
Frequency of Tumor Response at 9 Months After Last Treatment
Time frame · Baseline through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to quantify tumor response by comparison of baseline and last follow-up visit (6-9 months after last treatment) diagnostic CT/MRI scans.
Percentage of Patients With Grade 4 or Higher Renal Adverse Event.
Time frame · Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
The percentage of patients who experience a grade 4 or higher renal adverse event. Renal adverse events were graded using CTCAE v4.0 criteria.
Percentage of Patients With Grade 4 or Higher Irreversible Adverse Events
Time frame · Initiation of treatment through last follow-up visit (6-9 months after last treatment), up to approximately 10-13 months.
The percentage of patients who experience a grade 4 or higher irreversible adverse event. Adverse events were graded using CTCAE v4.0 criteria.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| 90Y-DOTA-tyr3-Octreotide | 0 |
| Group | Value (Participants) |
|---|---|
| 90Y-DOTA-tyr3-Octreotide | 0 |
| Group | Value (Participants) |
|---|---|
| 90Y-DOTA-tyr3-Octreotide | 0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 90Y-DOTA-tyr3-OctreotidePatients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry. 90Y-DOTA tyr3-Octreotide: 90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors. 68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan: 68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors. Amino Acids: This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys. | 5 / 39 | 14 / 39 | 37 / 39 |
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