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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03936426




Registration number
NCT03936426
Ethics application status
Date submitted
29/04/2019
Date registered
3/05/2019
Date last updated
20/04/2020

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, Non- Randomised, Phase I-IIa Theranostic Clinical Trial
Secondary ID [1] 0 0
CL02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningioma 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cu-64 SARTATE and Cu-67 SARTATE

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.


Treatment: Drugs: Cu-64 SARTATE and Cu-67 SARTATE
Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of multiple doses of Cu-67 SARTATE using CTCAE version 4.03
Timepoint [1] 0 0
55 weeks
Primary outcome [2] 0 0
Safety and tolerability of a single dose of Cu-64 SARTATE using CTCAE version 4.03
Timepoint [2] 0 0
56 weeks
Secondary outcome [1] 0 0
Absorbed dose of Cu-64 SARTATE in target, non-target organs and whole body.
Timepoint [1] 0 0
1, 4 and 24 hours post administration of Cu-64 SARTATE.
Secondary outcome [2] 0 0
Absorbed dose of Cu-67 SARTATE in target, non-target organs and whole body.
Timepoint [2] 0 0
1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Secondary outcome [3] 0 0
Maximum and mean SUV of Cu-64 SARTATE in target organs and SSTR binding lesions.
Timepoint [3] 0 0
1, 4 and 24 hours post administration of Cu-64 SARTATE.
Secondary outcome [4] 0 0
Maximum and mean SUV of Cu-67 SARTATE in target organs and SSTR binding lesions.
Timepoint [4] 0 0
1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Secondary outcome [5] 0 0
Activity of Cu-64 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose.
Timepoint [5] 0 0
1, 4 and 24 hours post administration of Cu-64 SARTATE.
Secondary outcome [6] 0 0
Activity of Cu-67 SARTATE in target and non-target organs and SSTR binding lesions as a percentage of the administered dose.
Timepoint [6] 0 0
1, 4, 24 and 96 hours post administration of Cu-67 SARTATE.
Secondary outcome [7] 0 0
Objective Response
Timepoint [7] 0 0
At 6 weeks post second administration of Cu-67 SARTATE, as well as at 6 and 12 weeks following the fourth administration.
Secondary outcome [8] 0 0
Qualitative analysis of PET/CT scans post administration of Cu-64 SARTATE.
Timepoint [8] 0 0
1, 4 and 24 hours post administration of Cu-64 SARTATE.
Secondary outcome [9] 0 0
Qualitative analysis of SPECT/CT scans post administration of Cu-67 SARTATE.
Timepoint [9] 0 0
1, 4, 24 and 96 hours post administration of Cu-67 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 Cu-64 SARTATE:

1. Estimated glomerular filtration rate (eGFR) greater than 40ml/min as measured
using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3.0
x upper limit of normal (ULN).

3. 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 Cu-67 SARTATE.

8. A female participant is eligible to participate if she is of:

1. 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].

2. 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.

3. Female participants must agree to use contraception until four weeks after the
last dose of Cu-67 SARTATE.
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 24 hours prior to Day 0.

6. 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.

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.

11. Peptide receptor radionuclide therapy (PRRT) at any time prior to enrolment in the
study.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/09/2019
Sample size
Target
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2065 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Clarity Pharmaceuticals Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03936426
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Geoffrey Schembri, MD
Address 0 0
Royal North Shore Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03936426