Phase 2
N=12
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
Acromegaly · Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02299089 ↗Enrolled (actual)
12
Serious AEs
4.2%
Results posted
Dec 2017
Primary outcome: Primary: Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC — 6.23; 24.1; 27.8; 39.9 day*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- octreotide FluidCrystal® injection depot (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Camurus AB
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC |
6.23; 24.1; 27.8; 39.9 | — |
| PRIMARY Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. |
92.9; 72.4; 72.9; 135; 95.6; 78.5 | — |
| PRIMARY Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough |
1.32; 0.403; 1.80; 1.81; 1.03; 1.01 | — |
| PRIMARY Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax |
0.349; 1.41; 1.68; 2.48 | — |
| PRIMARY Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough |
1.32; 0.403; 1.80; 1.81; 1.03; 1.01 | — |
| PRIMARY Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. |
10.4; 13.4; 6.33; 16.3; 10.6; 11.3 | — |
| SECONDARY Number of Adverse Events and Serious Adverse Events |
2; 4; 0; 2; 4; 2 | — |
| SECONDARY CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) |
2; 1; 1; 1 | — |
| SECONDARY CAM2029 Effect on Growth Hormone (GH) (Acromegaly) |
2; 2; 1; 0 | — |
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-differentiated NET, with carcinoid symptoms.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02299089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.