To Evaluate the Optimal Dose of 68Ga-OPS202 as a PET (Positron Emission Tomography) Imaging Agent in Subjects With Gastroenteropancreatic Neuroendocrine Tumour (GEP-NET)

Ipsen

Status and phase: Completed; Phase 2

Conditions: Gastro-Enteropancreatic Neuroendocrine Tumor

Treatments: Drug: Satoreotide trizoxetan 30-45μg; Drug: Satoreotide trizoxetan 5-20μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03220217

D-FR-01070-002

2016-004928-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of this clinical research is to confirm the optimal dose of 68Ga-satoreotide trizoxetan (68Ga-IPN01070), formerly 68Ga-OPS202, as a PET imaging agent to be used to detect and localize gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs). 68Ga-IPN01070 is a radiolabelled imaging agent to be used in association with Positron-Emission-Tomography (PET). 68Ga-IPN01070 is made of two main components: 1) IPN01070, an antagonistic somatostatin analogue which binds to the somatostatin receptor (type 2) present on the surface of the tumor cells and 2) Gallium-68, a radioisotope that combined with IPN01070 can be seen in the PET scanner.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification 2010)
• Confirmed presence of somatostatin receptors (type 2) on technically evaluable tumour lesions documented by a positive Somatostatin Receptor Scan acquired within 6 months prior to screening (Visit 1) and showing minimally two lesions in at least one of the key organs; these images shall be available to be sent to the imaging core lab electronically to ascertain quality and admissibility
• Body weight between 50 kg (110 lb) and 110 kg (243 lb), inclusive
• Adequate bone marrow, liver and renal function
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2

Exclusion criteria

• Fewer than five lesions in total and more than 25 lesions/organ detected by the previous somatostatin receptor scan in key organs: liver, lymph nodes, bone or lungs
• Subject who have received treatment of any somatostatin analogue, including Somatuline® Autogel® /Depot®, Sandostatin® LAR within 28 days, and Sandostatin® within 24 hours prior to first 68Ga-OPS202 administration
• Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide
• Any condition that precludes the proper performance of PET and/or CT scan: a) Subjects who are not able to tolerate the CT contrast agent, b) Subjects with metal implants or arthroplasty, or any other objects that might interfere with the PET and/or CT analysis, c) Subjects unable to raise arms for prolonged imaging purposes, d) Subjects unable to lie still for the entire imaging time, e) Subjects weighing greater than 110 kg (243 lb)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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29 participants in 3 patient groups

5-20μg/40-80 MBq, 30-45μg/100-140 MBq

Experimental group

Description:

Subjects will receive a first intravenous (i.v.) injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 40 to 80 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 100 to 140 MBq.

Treatment:

Drug: Satoreotide trizoxetan 5-20μg

Drug: Satoreotide trizoxetan 30-45μg

5-20μg/100-140 MBq, 30-45μg/160-200 MBq

Experimental group

Description:

Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 100 to 140 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 160 to 200 MBq.

Treatment:

Drug: Satoreotide trizoxetan 5-20μg

Drug: Satoreotide trizoxetan 30-45μg

5-20μg/160-200 MBq, 30-45μg/40-80 MBq

Experimental group

Description:

Subjects will receive a first i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 5 to 20 μg and a radioactivity dose range 160 to 200 MBq. After 15 to 21 days the subjects will receive a second i.v. injection of satoreotide trizoxetan with a peptide mass dose range of 30-45 μg and a radioactivity dose range 40 to 80 MBq.

Treatment:

Drug: Satoreotide trizoxetan 5-20μg

Drug: Satoreotide trizoxetan 30-45μg