67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04023331|
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : June 9, 2021
|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|
|Actual Study Start Date :||August 18, 2020|
|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 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 and best response [ Time Frame: 6 to 8 weeks post final therapy ]For patients receiving at least 1 administration of 67Cu-SARTATE, as assessed by INRC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023331
|Contact: Clarity Pharmaceuticals||+61 (0) 2 9209 firstname.lastname@example.org|
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