A Phase 1/2 interventional study of Cu-64 SARTATE and Cu-67 SARTATE in Meningioma, sponsored by Clarity Pharmaceuticals Ltd. Completed at 1 site in Australia. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2020-04-20.
Sponsored by Clarity Pharmaceuticals Ltd · Phase 1/2, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Meningioma; 87 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 161 interventional studies indexed under Meningioma.
Browse Meningioma studies →Clarity Pharmaceuticals Ltd is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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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:
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.
Drug: Cu-64 SARTATE and Cu-67 SARTATE
Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug
Also known as: SARTATE, copper SARTATE, Cu-SARTATE, 64Cu-SARTATE, 67Cu-SARTATE, Cu-64 SARTATE, Cu-67 SARTATE, 64/67Cu-SARTATE, Cu-64/67 SARTATE
Safety and tolerability of multiple doses of Cu-67 SARTATE using CTCAE version 4.03
Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting.
Time frame: 55 weeks
Safety and tolerability of a single dose of Cu-64 SARTATE using CTCAE version 4.03
Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting.
Time frame: 56 weeks
Absorbed dose of Cu-64 SARTATE in target, non-target organs and whole body.
Absorbed doses (mSv/MBq) will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE.
Time frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE.
Absorbed dose of Cu-67 SARTATE in target, non-target organs and whole body.
Absorbed doses (mSv/MBq) will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Time frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Maximum and mean SUV of Cu-64 SARTATE in target organs and SSTR binding lesions.
Maximum and mean SUV will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE.
Time frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE.
Maximum and mean SUV of Cu-67 SARTATE in target organs and SSTR binding lesions.
Maximum and mean SUV will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Time frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Activity of Cu-64 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose.
The percentage of the administered dose will be calculated using PET/CT scans acquired at 1, 4 and 24 hours post administration of Cu-64 SARTATE.
Time frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE.
Activity of Cu-67 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose.
The percentage of the administered dose will be calculated using SPECT/CT scans acquired at 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Time frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Objective Response
Objective response to therapy will be assessed according to the RANO Response Criteria for Meningioma, as measured by MRI and clinical status.
Time frame: At 6 weeks post second administration of Cu-67 SARTATE, as well as at 6 and 12 weeks following the fourth administration.
Qualitative analysis of PET/CT scans post administration of Cu-64 SARTATE.
Qualitative analysis of PET/CT scans to identify uptake patterns.
Time frame: 1, 4 and 24 hours post administration of Cu-64 SARTATE.
Qualitative analysis of SPECT/CT scans post administration of Cu-67 SARTATE.
Qualitative analysis of SPECT/CT scans to identify uptake patterns.
Time frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Plan to share: No
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Clarity Pharmaceuticals Ltd