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Trial registered on ANZCTR


Registration number
ACTRN12618000309280
Ethics application status
Approved
Date submitted
19/02/2018
Date registered
1/03/2018
Date last updated
28/01/2020
Date data sharing statement initially provided
25/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Peptide Receptor Radionuclide Therapy administered to Participants with
Meningioma with 67Cu-SARTATE™
Scientific title
Peptide Receptor Radionuclide Therapy administered to Participants with
Meningioma with 67Cu-SARTATE™: A single-centre, open-label, nonrandomised,
Phase I-IIa Theranostic Clinical Trial
Secondary ID [1] 293373 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningioma 305498 0
Condition category
Condition code
Cancer 304749 304749 0 0
Brain
Cancer 305907 305907 0 0
Head and neck
Cancer 305908 305908 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200MBq of 64Cu-MeCOSar-Octreotate ("64Cu-SARTATE") given as a single bolus intravenous injection at day 1 to demonstrate targeted uptake of SARTATE. Based on this, 1 to 4 weeks post 64Cu-SARTATE administration, Participants will the receive up to 4 individualised doses of 67Cu-MeCOSar-Octreotate ("67Cu-SARTATE"). There will be a minimum of 6 weeks between each 67Cu-SARTATE dose administration. Individual activity administered per dose will not exceed 15 GBq. Participants must meet the predetermined safety criteria, as assessed by haematology, biochemistry, and coagulation pathology results, to be eligible to receive the next dose of 67Cu-SARTATE.
Intervention code [1] 299627 0
Diagnosis / Prognosis
Intervention code [2] 299628 0
Treatment: Drugs
Comparator / control treatment
No comparator or control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303967 0
Report adverse clinical, biochemical or haematological events following 67Cu-SARTATE administration, as assessed via vital signs, pathology tests (haematology, biochemistry, urinalysis, coagulation, whole blood 67Cu concentration assay) physical examinations, ECGs.

Adverse Events associated with 67Cu-SARTATE are not yet known. Possible adverse events include anaphylaxis, decrease in blood cell count, decrease in kidney function, fatigue and flushing.
Timepoint [1] 303967 0
Recordings at:
- Day 0, Day 1, Day 2 of the first therapy cycle (conducted 1-4 weeks after enrolment)
- Day 0, Day 1, Day 2 of the second therapy cycle (conducted 6-12 weeks after cycle 1)
- Efficacy Visit conducted at 4-10 weeks after the second therapy cycle
- Day 0, Day 1, Day 2 of the third therapy cycle (conducted 6-12 weeks after cycle 2)
- Day 0, Day 1, Day 2 of the fourth therapy cycle (conducted 6-12 weeks after cycle 3)
- Exit Visit conducted at 12 weeks after the fourth therapy cycle
- Safety Visits conducted every 14 days between the therapy cycles and study Exit Visit
Secondary outcome [1] 340552 0
Determine the response rate for patients receiving at least 2 administrations of 67Cu-SARTATE, indicated by tumour volume as measured by MRI (as defined by the RANO response criteria).
Timepoint [1] 340552 0
Screening, Efficacy Visit. End of study visit. Efficacy visit will be completed 6 weeks post administration of the second & fourth doses of 67Cu-SARTATE. Exit Visit will be conducted at 12 weeks post administration of final dose of 67Cu-SARTATE.
Secondary outcome [2] 343469 0
At 1, 4 and 24 hours post administration of 64Cu-SARTATE and 67Cu-SARTATE, compare:
Visual comparison of PET and SPECT scans to confirm similarity of uptake patterns..
Timepoint [2] 343469 0
1hr, 4hrs and 24hrs following administration of 64Cu-SARTATE and every administration of 67Cu-SARTATE.
Secondary outcome [3] 343470 0
At 1, 4 and 24 hours post administration of 64Cu-SARTATE and 67Cu-SARTATE, compare: activity in target & non-target organs as a percentage of the administered dose, measured by PET/SPECT scans at the protocol defined time points.
Timepoint [3] 343470 0
1hr, 4hrs and 24hrs following administration of 64Cu-SARTATE and every administration of 67Cu-SARTATE.
Secondary outcome [4] 343471 0
At 1, 4 and 24 hours post administration of 64Cu-SARTATE and 67Cu-SARTATE, compare: Maximum and mean Standardized Uptake Values (SUVs) in target and non-target organs, measured by PET/SPECT scans.
Timepoint [4] 343471 0
1hr, 4hrs and 24hrs following administration of 64Cu-SARTATE and every administration of 67Cu-SARTATE.
Secondary outcome [5] 343472 0
At 1, 4 and 24 hours post administration of 64Cu-SARTATE and 67Cu-SARTATE, compare:
Absorbed dose (mSv/MBq) in target, non-target organs and whole body, measured by PET/SPECT scans.
Timepoint [5] 343472 0
1hr, 4hrs and 24hrs following administration of 64Cu-SARTATE and every administration of 67Cu-SARTATE.

Eligibility
Key inclusion criteria
1. Signed informed consent.
2. Age greater than or equal to 50 years.
3. Life expectancy greater than or equal to 3 months.
4. Has adequate organ function as defined by the following laboratory values obtained within 28 days prior to administration of 64CuSARTATE:
a. Estimated glomerular filtration rate (eGFR) greater than 40ml/min as measured using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
b. Aspartate aminotransferase (AST) and alanine aminotransferase
(ALT) less than 3.0 x upper limit of normal (ULN).
c. QT interval less than /=450msec as measured by 12 lead ECG.
5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2.
6. 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.
7. Male participants must agree to use contraception methods from Day 0 through to 4 weeks after the last dose of 67Cu-SARTATE.
8. A female participant is eligible to participate if she is of:
a. 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].
b. 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.
c. Female participants must agree to use contraception until four weeks after the last dose of 67Cu-SARTATE.

To be eligible for 67Cu-SARTATE administration:
9. 64Cu-SARTATE uptake in tumour higher than that of liver at 24 hrs.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known sensitivity or allergy to somatostatin analogues.
2. Participants who have received interventional treatment for their meningioma within the four weeks prior to Day 0.
3. Any major surgery within the four weeks prior to Day 0.
4. Any additional planned interventions, including surgery or radiation therapy that would interfere with safety or efficacy assessments.
5. Treatment with long acting somatostatin analogues within 28 days prior to Day 0. Treatment with short acting somatostatin analogues within 24hrs prior to Day 0.
6. Any other malignancy in the past 5 years except for 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.
7. Breastfeeding females and pregnant females.
8. Treatment with any investigational agent received within four weeks prior to Day 0.
9. Participants unwilling or unable to comply with protocol requirements.
10. Urinary or faecal incontinence of sufficient degree to be of concern for contamination risk in the opinion of the Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics are used to describe the basic features of the data in this study. They provide simple summaries about the sample and the measures. For the 1st primary objective, the safety and tolerability following administration of 67Cu-SARTATE adverse clinical events will be evaluated. The number of participants who demonstrate an adverse response following 67Cu-SARTATE administration, and its 95% confidence interval (CI) will be reported. The estimated true adverse event rate will be calculated using the Clopper-Pearson method. The imaging scan results at 1, 4 and 24 hours post administration of 64Cu-SARTATE and 67Cu-SARTATE, including the qualitative analysis findings from the PET/CT scans will be compared to SPECT/CT scans to confirm if uptake patterns are similar/consistent. Descriptive statistics will be assessed to evaluate activity in target & non-target organs, which will be analysed as a percentage of the administered dose, at 1, 4 and 24 hours post administration of 64Cu-SARTATE and 67Cu-SARTATE. Maximum and mean Standardized Uptake Values (SUVs) in target and non-target organs will be compared at 1, 4 and 24 hours post administration of 64Cu-SARTATE and 67Cu-SARTATE. Basic descriptive statistics of the absorbed dose (mSv/MBq) will be assessed for target and non-target organs, as well as for the whole body dose. The response rate, as indicated by tumour volume as measured by MRI, and defined by the RANO assessment criteria; will be evaluated using the Efficacy Set. The utility of repeated 67Cu-SARTATE SPECT scans will be assessed by evaluating clinical response after each cycle, using the Efficacy data (as defined by the RANO assessment criteria). Dosimetry estimates, as calculated based on the 64Cu-SARTATE PET scans, will also be compared with actual exposure.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2018
Actual
9/07/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
31/10/2018
Date of last data collection
Anticipated
25/03/2021
Actual
19/09/2019
Sample size
Target
6
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9398 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 18098 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 297996 0
Commercial sector/Industry
Name [1] 297996 0
Clarity Pharmaceuticals Ltd.
Country [1] 297996 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Clarity Pharmaceuticals Ltd.
Address
National Innovation Centre,
4 Cornwallis St, Eveleigh NSW 2015
Country
Australia
Secondary sponsor category [1] 297320 0
None
Name [1] 297320 0
Address [1] 297320 0
Country [1] 297320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299035 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 299035 0
Ethics committee country [1] 299035 0
Australia
Date submitted for ethics approval [1] 299035 0
18/10/2017
Approval date [1] 299035 0
11/12/2017
Ethics approval number [1] 299035 0
HREC/17/SVHM/238

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79066 0
Dr Geoffrey Schembri
Address 79066 0
Department of Nuclear Medicine, ROYAL NORTH SHORE HOSPITAL , Reserve Road, St Leonards, NSW 2065.
Country 79066 0
Australia
Phone 79066 0
+61 2 9926 4440
Fax 79066 0
Email 79066 0
gschembri@med.usyd.edu.au
Contact person for public queries
Name 79067 0
Geoffrey Schembri
Address 79067 0
Department of Nuclear Medicine, ROYAL NORTH SHORE HOSPITAL , Reserve Road, St Leonards, NSW 2065.
Country 79067 0
Australia
Phone 79067 0
+61 2 9926 4440
Fax 79067 0
Email 79067 0
gschembri@med.usyd.edu.au
Contact person for scientific queries
Name 79068 0
Geoffrey Schembri
Address 79068 0
Department of Nuclear Medicine, ROYAL NORTH SHORE HOSPITAL , Reserve Road, St Leonards, NSW 2065.
Country 79068 0
Australia
Phone 79068 0
+61 2 9926 4440
Fax 79068 0
Email 79068 0
gschembri@med.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All patient data collected will be anonymised, and will be pooled and statistically analysed in aggregate form. Individual patient data will not be shared externally to the sponsor or to anyone outside the study team.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIAn introduction to the clinical practice of theranostics in oncology2018https://doi.org/10.1259/bjr.20180440
EmbaseRadioimmunotherapy for solid tumors: spotlight on Glypican-1 as a radioimmunotherapy target.2021https://dx.doi.org/10.1177/17588359211022918
N.B. These documents automatically identified may not have been verified by the study sponsor.