WHO ICTRP trial
A trial to assess efficacy and safety of octreotide subcutaneous depot in…
EUCTR2021-000849-40-HU · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-000849-40-HU |
|---|---|
| Public title | A trial to assess efficacy and safety of octreotide subcutaneous depot in patients with GEP-NET |
| Scientific title | A randomized, multi-center, open-label, active-controlled Phase 3 trial to assess the efficacy and safety of octreotide subcutaneous depot (CAM2029) versus octreotide LAR or lanreotide ATG in patients with gastroenteropancreatic neuroendocrine tumors. |
| Primary sponsor | Camurus AB |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | France;United States;Hungary;Canada;Spain;Belgium;Romania;Netherlands;United Kingdom;Italy |
| Conditions | gastroenteropancreatic neuroendocrine tumors MedDRA version: 20.0 Level: PT Classification code 10077559 Term: Gastroenteropancreatic neuroendocrine tumour disease System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified… |
| Interventions | Product Name: CAM2029 (Octreotide subcutaneous depot) Product Code: CAM2029 Pharmaceutical Form: Prolonged-release solution for injection INN or Proposed INN: octreotide Current Sponsor code: CAM2029 Other descriptive name: OCTREOTIDE… |
| Registration date | Oct 8, 2021 |
| Target size | 302 |
| Secondary IDs | HS-19-657 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: