Clinical trial · Interventional
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Patients With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin® LAR®
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acromegaly | — | UNRESOLVED | — |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| octreotide FluidCrystal® injection depot | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- CAM2029 10 mg (NET)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
- interventionNames
- Drug: octreotide FluidCrystal® injection depot
- type
- EXPERIMENTAL
- label
- CAM2029 20 mg (NET)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
- interventionNames
- Drug: octreotide FluidCrystal® injection depot
- type
- EXPERIMENTAL
- label
- CAM2029 10 mg (Acromegaly)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Acromegaly: * Male or female patients ≥18 years of age * Acromegaly currently treated with Sandostatin LAR NET: * Male or female patients ≥18 years of age * Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing) * Currently treated with Sandostatin LAR for symptom control Exclusion Criteria: Acromegaly: * Inadequate bone marrow function * Abnormal coagulation or chronic treatment with warfarin or coumarin derivates * Impaired liver, cardiac and/or renal function * Known gallbladder, bile duct disease or pancreatitis * Diabetes with poorly controlled blood glucose levels despite adequate therapy * Hypothyroidisms not adequately treated NET: * Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine carcinoma and small cell carcinoma * Carcinoid syndrome refractory to treatment with conventional doses of somatostatin analogues (SSAs) * Inadequate bone marrow function * Abnormal coagulation or chronic treatment with warfarin or coumarin derivates * Impaired liver, cardiac and/or renal function * Known gallbladder, bile duct disease or pancreatitis * Short-bowel syndrome * Diabetics with poorly controlled blood glucose levels despite adequate therapy * Hypothyroidism, not adequately treated
References
Publications (1)
- DERIVEDPavel M, Borson-Chazot F, Cailleux A, Horsch D, Lahner H, Pivonello R, Tauchmanova L, Darstein C, Olsson H, Tiberg F, Ferone D. Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study. Cancer Chemother Pharmacol. 2019 Feb;83(2):375-385. doi: 10.1007/s00280-018-3734-1. Epub 2018 Dec 8. PMID 30535537