| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningioma | Drug: Cu-64 SARTATE and Cu-67 SARTATE | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 5 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™: A Single-centre, Open-label, Non- Randomised, Phase I-IIa Theranostic Clinical Trial |
| Actual Study Start Date : | July 9, 2018 |
| Actual Primary Completion Date : | September 19, 2019 |
| Actual Study Completion Date : | September 19, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: SARTATE
All participants will receive 200 MBq of Cu-64 SARTATE given as a single bolus intravenous injection at Day 0. Participants will receive up to four administrations of Cu-67 SARTATE via a slow intravenous infusion over 30 minutes, 6 to 12 weeks apart. Individual activity administered per cycle will not exceed 5.1 GBq.
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Drug: Cu-64 SARTATE and Cu-67 SARTATE
Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug
Other Names:
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of Cu-64 SARTATE:
A female participant is eligible to participate if she is of:
Exclusion Criteria:
| Australia, New South Wales | |
| Royal North Shore Hospital | |
| Sydney, New South Wales, Australia, 2065 | |
| Principal Investigator: | Geoffrey Schembri, MD | Royal North Shore Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 29, 2019 | ||||
| First Posted Date ICMJE | May 3, 2019 | ||||
| Last Update Posted Date | April 20, 2020 | ||||
| Actual Study Start Date ICMJE | July 9, 2018 | ||||
| Actual Primary Completion Date | September 19, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™ | ||||
| Official Title ICMJE | Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™: A Single-centre, Open-label, Non- Randomised, Phase I-IIa Theranostic Clinical Trial | ||||
| Brief Summary | The primary purpose of this study is to investigate the safety and tolerability of a single dose of Cu-64 SARTATE and multiple doses of Cu-67 SARTATE administered to participants with meningioma. All participants in this study will be injected with a single dose of Cu-64 SARTATE to demonstrate how it is absorbed in the body. Then participants will receive individualised doses of Cu-67 SARTATE for up to 4 cycles. | ||||
| Detailed Description | This is a single centre, open label, non-randomised, single cohort, multiple dose study of Cu-67 SARTATE administered to male and female participants diagnosed with grade I, II, or III meningioma. The maximum allowable dose will be calculated using dosimetry data acquired from PET/CT scans completed during a pre-treatment diagnostic & dosimetry phase using Cu-64 SARTATE, a structurally identical molecule radiolabelled with copper-64 (Cu-64), instead of copper-67 (Cu-67). Approximately 6 participants will be enrolled in the study. Participants will have up to 4 therapy cycles (6-12 weeks apart). Safety visits will occur between each cycle at bi-weekly intervals to ensure the participant meets the safety criteria prior to their next therapy. An efficacy assessment will be conducted following cycle 2 to determine if a subsequent 2 cycles of therapy will be administered. Participants who complete all four cycles of Cu-67 SARTATE therapy, will complete their final study visit at 12 weeks post administration of cycle 4. | ||||
| 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 | Meningioma | ||||
| Intervention ICMJE | Drug: Cu-64 SARTATE and Cu-67 SARTATE
Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug
Other Names:
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| Study Arms ICMJE | Experimental: SARTATE
All participants will receive 200 MBq of Cu-64 SARTATE given as a single bolus intravenous injection at Day 0. Participants will receive up to four administrations of Cu-67 SARTATE via a slow intravenous infusion over 30 minutes, 6 to 12 weeks apart. Individual activity administered per cycle will not exceed 5.1 GBq.
Intervention: Drug: Cu-64 SARTATE and Cu-67 SARTATE
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| Publications * | Not Provided | ||||
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* 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 | Completed | ||||
| Actual Enrollment ICMJE |
5 | ||||
| Original Estimated Enrollment ICMJE |
6 | ||||
| Actual Study Completion Date ICMJE | September 19, 2019 | ||||
| Actual Primary Completion Date | September 19, 2019 (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 | 50 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Australia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03936426 | ||||
| Other Study ID Numbers ICMJE | CL02 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Clarity Pharmaceuticals Ltd | ||||
| Study Sponsor ICMJE | Clarity Pharmaceuticals Ltd | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Clarity Pharmaceuticals Ltd | ||||
| Verification Date | April 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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