67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma
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|ClinicalTrials.gov Identifier: NCT04023331|
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma||Drug: 67Cu-SARTATE Drug: 64Cu-SARTATE||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma: A Multi-center, Dose-escalation, Open-label, Non-randomized, Phase 1-2a Theranostic Clinical Trial|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
64Cu-SARTATE - patients will receive a bolus injection of 64Cu-SARTATE during screening, and following each 67Cu-SARTATE Therapy Cycle at a rate of 2.0 MBq/kg.
67Cu-SARTATE - In the dose escalation phase, patients will receive a single administration of 67Cu-SARTATE as a slow IV infusion (dose will be determined based on cohort allocation). In the expansion phase, patients will receive up to 2 administrations of 67Cu-SARTATE a the MTD level as a slow IV infusion.
Other Name: Cu-67 SARTATE, copper 67 SARTATE
Other Name: Cu-64 SARTATE, copper 64 SARTATE
- Maximum Tolerated Dose of 67Cu-SARTATE [ Time Frame: 6 weeks ]MDT as determined by cohort observations of DLTs
- Safety and tolerability of Cu-67 SARTATE using CTCAE version 4.03 [ Time Frame: Up to 12 months ]Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
- Safety and tolerability of Cu-64 SARTATE using CTCAE version 4.03 [ Time Frame: Up to 12 months ]Safety will be assessed via vital signs, pathology tests (hematology, biochemistry, urinalysis, coagulation), physical examinations, ECGs and spontaneous AE reporting.
- Objective response rate [ Time Frame: 6 to 8 weeks post final therapy ]For patients receiving at least 1 administration of 67Cu-SARTATE, as assessed by INRC.