177Lu-OPS201 phase I/II study for the therapy of NETs
Research type
Research Study
Full title
An international multi-center, 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).
IRAS ID
192339
Contact name
Anja Zehnder
Contact email
Sponsor organisation
OctreoPharm Sciences GmbH
Eudract number
2015-002867-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 8 months, 26 days
Research summary
The purpose of this early phase study is to see how safe and how well tolerated peptide receptor radionuclide therapy (PRRT) with 177Lu-OPS201 is. The treatment will be given in three cycles (8 weeks apart) to patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (NETs).
The study will be conducted in 5-10 hospitals in Europe, USA and Australia and 45 patients will be treated. The study is conducted in 2 phases, Phase A and B. Phase A will treat 15 patients with low activity study drug and Phase B will treat 30 patients with higher doses of study drug. The treatment dose in Phase B will decided by a safety review committee after patients in Phase A have been treated.
Patients will be treated for approximately 9 months and then followed up with regular visits to the hospital for up to 2 years. At each cycle, patients may be hospitalised for 2-8 days (cycle 1) and for 2-4 days (cycles 2 and 3). Patients will attend Out Patient Clinic for safety follow-up 4 weeks after each cycle and for a further safety visit 8 weeks after cycle 3. During Long-Term Follow-up the patient will return to the out-patient clinic for 1 day every 3 months for up to two years; they will complete safety evaluations and CT/MRI will be conducted to monitor progression free survival and long-term safety.
Throughout the study the radiation distribution in the body and the effects on the organs will be measured by scans and blood samples. Quality of life will also be measured. How well treatment has worked will be assessed over a two year period after the end of the core treatment. The main objective of the study is to look at how safe this study drug is and how well it works.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0138
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion