Status:
COMPLETED
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
Lead Sponsor:
Camurus AB
Collaborating Sponsors:
Novartis
Conditions:
Acromegaly
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-differ...
Detailed Description
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-differ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02299089
Start Date
January 1 2015
End Date
June 1 2016
Last Update
December 15 2017
Active Locations (10)
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1
Hospices Civils de Lyon
Bron, France
2
CHU Rouen, Hôpital Charles Nicolle
Rouen, France
3
Abteilung: Klinische Studien
Bad Berka, Germany
4
Charité Campus Virchow Klinikum
Berlin, Germany