Condition or disease | Intervention/treatment | Phase |
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Neuroblastoma | Drug: 67Cu-SARTATE Drug: 64Cu-SARTATE | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 34 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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Experimental: 67Cu-SARTATE
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. |
Drug: 67Cu-SARTATE
67Cu-labelled MeCOSar-Tyr3-octreotate
Other Name: Cu-67 SARTATE, copper 67 SARTATE
Drug: 64Cu-SARTATE 64Cu-labelled MeCOSar-Tyr3-octreotate
Other Name: Cu-64 SARTATE, copper 64 SARTATE
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Clarity Pharmaceuticals | +61 (0) 2 9209 4037 | clinicaltrials@claritypharmaceuticals.com |
United States, New York | |
Memorial Sloan Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Principal Investigator: Neeta Pandit-Taskar, MD | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Centre | Recruiting |
Cincinnati, Ohio, United States, 45229 | |
Principal Investigator: Brian Weiss, MD | |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Principal Investigator: Jacquline Kraveka, MD | |
United States, Texas | |
University of Texas Southwestern Medical Centre | Recruiting |
Dallas, Texas, United States, 75390 | |
Principal Investigator: Tanya Watt, MD | |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Principal Investigator: Mario Otto, MD |
Tracking Information | |||||
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First Submitted Date ICMJE | July 14, 2019 | ||||
First Posted Date ICMJE | July 17, 2019 | ||||
Last Update Posted Date | June 9, 2021 | ||||
Actual Study Start Date ICMJE | August 18, 2020 | ||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | 67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | The aim of this study is to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma. | ||||
Detailed Description | This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion phase. Dose escalation will be completed using a modified 3+3 study design with up to 4 Cohorts of increasing doses in MBq/kg. Pre-defined Dose Limiting Toxicities will be monitored for 6 weeks post administration of 67Cu-SARTATE. Once either the MTD for a single administration of 67Cu-SARTATE is established, or Cohort 4 has been completed, the study will be expanded to enroll an additional 10 subjects who will receive 2 therapy cycles of 67Cu-SARTATE at the MTD dose level. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neuroblastoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: 67Cu-SARTATE
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. Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
34 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 2022 | ||||
Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04023331 | ||||
Other Study ID Numbers ICMJE | CL04 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Clarity Pharmaceuticals Ltd | ||||
Study Sponsor ICMJE | Clarity Pharmaceuticals Ltd | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Clarity Pharmaceuticals Ltd | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |