MeningiomaPhase 1/2NCT03936426
Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™
A Phase 1/2 study testing Cu-64 SARTATE and Cu-67 SARTATE in people with Meningioma, run by Clarity Pharmaceuticals Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Cu-64 SARTATE and Cu-67 SARTATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jul 2018to 19 Sep 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Age greater than or equal to 50 years.
- Life expectancy greater than or equal to 3 months.
- Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of Cu-64 SARTATE:
- Estimated glomerular filtration rate (eGFR) greater than 40ml/min as measured using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3.0 x upper limit of normal (ULN).
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- QT interval less than /=450msec as measured by 12 lead ECG.
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
- Diagnosis of recurrent or progressive histologically confirmed WHO grade I-III meningioma which has failed standard of care therapies. Patients will be considered to have failed standard care when they have disease that is progressing despite standard treatment (primarily radiotherapy) or where, in the opinion of their treating physician, further standard therapy is considered to be of sufficiently high risk of complication as to warrant consideration of alternate therapies.
- Male participants must agree to use contraception methods from Day 0 through to 4 weeks after the last dose of Cu-67 SARTATE.
- A female participant is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) greater than 40 MlU/ml and oestradiol less than 40 pg/ml (less than 140 pmol/l) is confirmatory].
- Child-bearing potential and agrees to use contraception methods for an appropriate period of time (as determined by the Investigator) prior to Day 0 to sufficiently minimize the risk of pregnant females being enrolled. These measures are the combination of a barrier method AND established (greater than 2 cycles) hormonal methods (e.g. the oral contraceptive pill). Absolute sexual abstinence may be considered acceptable at the discretion of the investigator. Abstinence for the 12 days prior to therapy to allow for serum B-hCG assessment which should then ensure the patient is not pregnant prior to therapy administration.
- Female participants must agree to use contraception until four weeks after the last dose of Cu-67 SARTATE.
Who cannot join
- Known sensitivity or allergy to somatostatin analogues.
- Participants who have received interventional treatment for their meningioma within the four weeks prior to Day 0.
- Any major surgery within the four weeks prior to Day 0.
- Any additional planned interventions, including surgery or radiation therapy that would interfere with safety or efficacy assessments.
- Treatment with long acting somatostatin analogues within 28 days prior to Day 0. Treatment with short acting somatostatin analogues within 24 hours prior to Day 0.
- Any other malignancy in the past 5 years except for cervical intraepithelial neoplasia (CIN) of the cervix, squamous cell carcinoma (SCC) of the skin, basal cell carcinoma (BCC) of the skin or clinical insignificant prostate cancer not requiring prior therapy.
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- Breastfeeding females and pregnant females.
- Treatment with any investigational agent received within four weeks prior to Day 0.
- Participants unwilling or unable to comply with protocol requirements.
- Urinary or faecal incontinence of sufficient degree to be of concern for contamination risk in the opinion of the Investigator.
- Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Meningioma
- Being tested
- Cu-64 SARTATE and Cu-67 SARTATE
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cu-64 SARTATE and Cu-67 SARTATEDrug
Also called SARTATE, copper SARTATE, Cu-SARTATE, 64Cu-SARTATE
Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug
| Study group | Role | What they receive |
|---|---|---|
| SARTATE | Experimental | 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. Receives: Drug: Cu-64 SARTATE and Cu-67 SARTATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 56 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start9 Jul 2018
- Primary completion19 Sep 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clarity Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoffrey Schembri, MD, Principal investigator, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936426
- Sponsor's protocol ID
- CL02
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2019
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bailey DL, Willowson KP, Harris M, Biggin C, Aslani A, Lengkeek NA, Stoner J, Eslick ME, Marquis H, Parker M, Roach PJ, Schembri GP. 64Cu Treatment Planning and 67Cu Therapy with Radiolabeled [64Cu/67Cu]MeCOSar-Octreotate in Subjects with Unresectable Multifocal Meningioma: Initial Results for Human Imaging, Safety, Biodistribution, and Radiation Dosimetry. J Nucl Med. 2023 May;64(5):704-710. doi: 10.2967/jnumed.122.264586. Epub 2022 Dec 2.
PubMed 36460344
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03936426
- Acronym / sponsor ID
- CL02
- Conditions
- Meningioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Clarity Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 19 Sep 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARTATE | Experimental | Drug: Cu-64 SARTATE and Cu-67 SARTATEAll 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent.
- Age greater than or equal to 50 years.
- Life expectancy greater than or equal to 3 months.
- Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of Cu-64 SARTATE:
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
Key exclusion criteria (11 listed)
- Known sensitivity or allergy to somatostatin analogues.
- Participants who have received interventional treatment for their meningioma within the four weeks prior to Day 0.
- Any major surgery within the four weeks prior to Day 0.
- Any additional planned interventions, including surgery or radiation therapy that would interfere with safety or efficacy assessments.
- Treatment with long acting somatostatin analogues within 28 days prior to Day 0. Treatment with short acting somatostatin analogues within 24 hours prior to Day 0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cu-64 SARTATE and Cu-67 SARTATEAlso: SARTATE, copper SARTATE, Cu-SARTATE, 64Cu-SARTATECu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug | Drug | SARTATE |
Primary outcome
Safety and tolerability of multiple doses of Cu-67 SARTATE using CTCAE version 4.03
Time frame: 55 weeks
Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting.
Safety and tolerability of a single dose of Cu-64 SARTATE using CTCAE version 4.03
Time frame: 56 weeks
Safety will be assessed via vital signs, laboratory tests, physical examinations, ECGs and spontaneous adverse event reporting.
9 secondary outcomes
Absorbed dose of Cu-64 SARTATE in target, non-target organs and whole body.
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.
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.
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.
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.
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.
Time frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Objective Response
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.
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.
Time frame: 1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Derived from this study: PubMed 36460344Bailey DL, Willowson KP, Harris M, Biggin C, Aslani A, Lengkeek NA, Stoner J, Eslick ME, Marquis H, Parker M, Roach PJ, Schembri GP. 64Cu Treatment Planning and 67Cu Therapy with Radiolabeled [64Cu/67Cu]MeCOSar-Octreotate in Subjects with Unresectable Multifocal Meningioma: Initial Results for Human Imaging, Safety, Biodistribution, and Radiation Dosimetry. J Nucl Med. 2023 May;64(5):704-710. doi: 10.2967/jnumed.122.264586. Epub 2022 Dec 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Schembri, MD principal investigator
Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cu-64 SARTATE and Cu-67 SARTATE in people with Meningioma, run by Clarity Pharmaceuticals Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of multiple doses of Cu-67 SARTATE using CTCAE version 4.03 (time frame: 55 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.