We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02592707




Registration number
NCT02592707
Ethics application status
Date submitted
15/10/2015
Date registered
30/10/2015
Date last updated
3/06/2021

Titles & IDs
Public title
Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs
Scientific title
An International, Multicenter, Open-label Study to Evaluate Safety, Tolerability, Biodistribution, Dosimetry and Preliminary Efficacy of 177Lu-OPS201 for the Therapy of Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
Secondary ID [1] 0 0
2015-002867-41
Secondary ID [2] 0 0
D-FR-01072-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuroendocrine Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Satoreotide tetraxetan

Experimental: 177Lu-OPS201 - 177Lu-OPS201 will be administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)


Treatment: Drugs: Satoreotide tetraxetan
Satoreotide tetraxetan will be administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of 177Lu-OPS201 assessed by number of patients with treatment related adverse events using CTCAE v5.0
Timepoint [1] 0 0
during the whole study period of 34 months
Secondary outcome [1] 0 0
Area under the curve (AUC) of 177Lu-OPS201 per cycle in discernible thoracic and abdominal organs, target lesions and blood
Timepoint [1] 0 0
during the core study period of 10 months
Secondary outcome [2] 0 0
Maximal uptake (achieved in %) at the target lesions per cycle.
Timepoint [2] 0 0
during the core study period of 10 months
Secondary outcome [3] 0 0
Maximal uptake in discernible organs (%) and blood (%/mL) per cycle.
Timepoint [3] 0 0
during the core study period of 10 months
Secondary outcome [4] 0 0
Organs receiving the highest absorbed dose (Gy) for each cycle.
Timepoint [4] 0 0
during the core study period of 10 months
Secondary outcome [5] 0 0
Specific absorbed dose per organ (achieved in Gy/GBq) for each cycle.
Timepoint [5] 0 0
during the core study period of 10 months
Secondary outcome [6] 0 0
Cumulative absorbed organ doses (achieved in Gy).
Timepoint [6] 0 0
during the core study period of 10 months
Secondary outcome [7] 0 0
Preliminary therapeutic efficacy of 177Lu-OPS201 assessed by tumor response based on RECIST v1.1
Timepoint [7] 0 0
during the whole study period of 34 months
Secondary outcome [8] 0 0
Preliminary therapeutic efficacy of 177Lu-OPS201 assessed by monitoring of PFS (based on RECIST v1.1 status)
Timepoint [8] 0 0
during the whole study period of 34 months
Secondary outcome [9] 0 0
Quality of Life (QoL) questionnaire
Timepoint [9] 0 0
during the core study period of 10 months
Secondary outcome [10] 0 0
Terminal half-life of radioactivity concentrations of the radiopharmaceutical in blood
Timepoint [10] 0 0
during the first 7 days of cycle 1 of the core study period
Secondary outcome [11] 0 0
PK parameters of OPS201, if OPS201 levels are measurable in plasma and urine. - PK parameters of OPS201(including, but not limited to, maximum observed concentration (Cmax), AUC, elimination half-life (t1/2), apparent total body clearance of the drug from plasma (CL), apparent volume of distribution (Vd), cumulative amount of unchanged drug excreted into the urine (Ae), renal clearance of the drug from plasma (CLR)) will be derived using the non-compartmental approach on the individual plasma concentration-time profiles of OPS201 and on the individual urine concentrations
Timepoint [11] 0 0
during the first 3 days of cycle 1 of the core study period

Eligibility
Key inclusion criteria
1. Written informed consent.

2. Patients of either gender, aged = 18 years.

3. Women of childbearing potential (not surgically sterile or less than 2 years
postmenopausal) must use a medically accepted method of contraception and must agree
to continue use of this method for the duration of the study and for 6 months after
the last dose. Acceptable methods of contraception include abstinence, or double
contraception: steroidal contraceptive (oral, transdermal, implanted, and injected) in
conjunction with a barrier method (intrauterine device, condom etc.).

4. Male patients must use a medically accepted method of contraception and must agree to
continue use of this method for the duration of the study and for 6 months after the
last activity administration.

5. Karnofsky performance score = 60.

6. Life expectancy of at least 6 months.

7. Histologically confirmed diagnosis of -

- unresectable GEP NET (Grade I and Grade II according to WHO classification (2010,
Annex 01), functioning and non-functioning).

- unresectable "typical lung carcinoid" or "atypical lung carcinoid" are acceptable
(with the exception of Large Cell Bronchial Neuroendocrine Neoplasms and Small
Cell Lung Cancers) (Caplin 2015).

- malignant, unresectable pheochromocytoma or paraganglioma

8. Documentation of progressive disease based on RECIST v1.1 under prior anti-tumor
therapy within 6 months of entry in the study (although the progression might have
occurred more than 6 months before study entry). Patients should not have received
further anti-tumor therapy once disease progression is documented. The images of this
evaluation should be available for TGR evaluation.

9. In countries where sunitinib or everolimus are marketed, patients with GEP NET and
lung NET will be progressive under this prior anti-tumor treatment for the respective
indication. Patients not suitable for everolimus/sunitinib therapy according to a
tumor board decision (or comparable local practice) may also be enrolled into the
study. Patients having everolimus/sunitinib therapy should have a wash-out phase of =
4 weeks before the first treatment.

10. Measurable disease based on RECIST v1.1.

11. Confirmed presence of somatostatin receptors on technically evaluable tumor lesions
documented by a positive Somatostatin Receptor Scan performed within 6 months prior to
enrolment in the study.

12. Calculated GFR = 55 mL/min.

13. Blood test results as follows:

- Leukocytes: = 4*10^9/L

- Erythrocytes: = 3.5*12^9/L

- Platelets: = 100*10^9/L

- Albumin: > 30 g/L

- ALT, AST, AP: = 5 times ULN (upper limit of normal)

- Bilirubin: = 2 times ULN (2x 1.1 mg/dL)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known hypersensitivity to 177Lu, to DOTA, to JR11 or to any of the excipients of
177Lu-OPS201.

2. Any previous peptide receptor radionuclide therapy (PRRT).

3. Diagnosis of thymic NET.

4. Presence of active infection at screening or history of serious infection within the
previous 6 weeks.

5. Administration of any other investigational medicinal product within 60 days prior to
entry.

6. Prior or planned administration of a therapeutic radiopharmaceutical within 8
half-lives of the radionuclide including any time during the current study.

7. Any extensive radiotherapy = 3 months before enrolment.

8. Chemotherapy = 3 months before enrolment.

9. Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject
at high risk of renal toxicity during the study as assessed by the investigator.

10. Pregnant or breast-feeding women: A pregnancy test will be performed at the start of
the study for all female patients of childbearing potential (i.e. not surgically
sterile or up to 2 years postmenopausal).

11. Any uncontrolled significant medical, psychiatric or surgical condition (active
infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled
hypertension, poorly controlled diabetes mellitus [HbA1c =9%], uncontrolled congestive
heart disease, etc.) or laboratory findings that, in the opinion of the investigator,
might jeopardize the patient's safety or that would limit compliance with the
objectives and assessments of the study. Note: the patient should be able to tolerate
high volume load.

12. Current history of any malignancy other than NET within 5 years of enrolment except
for fully -resected non-melanoma skin cancer or cervical cancer in situ. Current
history of malignancy; patients with a secondary tumor in remission of > 5 years can
be included

13. Any mental condition rendering the patient unable to understand the nature, scope and
possible consequences of the study, and/or evidence of an uncooperative attitude.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre, Molecular Imaging and Targeted Therapeutics Laboratory - East Melbourne
Recruitment hospital [2] 0 0
Ramsay Hollywood Private Hospital, Department of Nuclear Medicine - Perth
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Canada
State/province [3] 0 0
Québec
Country [4] 0 0
Denmark
State/province [4] 0 0
Aarhus
Country [5] 0 0
France
State/province [5] 0 0
Nantes
Country [6] 0 0
Switzerland
State/province [6] 0 0
Basel
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ipsen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical phase I/II study is to investigate the safety and tolerability
of 177Lu-OPS201 used for the treatment of patients with neuroendocrine tumors (NETs).
Secondary objectives of these study are the assessment of biodistribution, dosimetry and
preliminary efficacy of 177Lu-OPS201.
Trial website
https://clinicaltrials.gov/show/NCT02592707
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ipsen Medical Director
Address 0 0
Ipsen
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
Other publications