TerminatedPhase 2ACTRN12618000309280

Peptide Receptor Radionuclide Therapy administered to Participants with Meningioma with 67Cu-SARTATE™

Peptide Receptor Radionuclide Therapy administered to Participants with Meningioma with 67Cu-SARTATE™: A single-centre, open-label, nonrandomised, Phase I-IIa Theranostic Clinical Trial

Sponsor

Clarity Pharmaceuticals Ltd.

Enrollment

6 participants

Start Date

Jul 9, 2018

Study Type

Interventional

Conditions

Meningioma

Summary

The primary purpose of this study is to investigate the safety and tolerability of multiple doses of 67Cu-SARTATE administered to participants with meningioma. Who is it for? You may be eligible to join this study if you are aged 50 years or over. Study details: All participants in this study will be injected with a single dose of 64Cu-SARTATE (a drug molecule) to demonstrate how it is absorbed in the body. Then participants will receive individualised doses of 67Cu-MeCOSar-Octreotate ("67Cu-SARTATE")for up to 4 cycles. It is hoped that this research will develop a product, which may help patients with meningioma.

Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Inclusion Criteria17

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 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.
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 67Cu-SARTATE.
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:
64Cu-SARTATE uptake in tumour higher than that of liver at 24 hrs.

Exclusion Criteria10

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 24hrs prior to Day 0.
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.
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.

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Interventions

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.