acromegaly
Conditions
Interventions
Product Name: CAM2029-BR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Octreotide
CAS Number: 83150-76-9
Other descriptive name: OCTREOTIDE HYDROCHLORIDE
Concentration unit: mg/ml m
Sponsors
Camurus AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients with Acromegaly; 1.Patients from whom written informed consent to participate in the study has been obtained prior to any screening procedures. 2.Male or female patients =18 years of age. 3.Patients with acromegaly currently being treated with no medical treatment for acromegaly other than Sandostatin LAR (also Longastatina LAR for Italy). 4.Patients currently receiving Sandostatin LAR at a stable dose of 10 mg, 20 mg or 30 mg i.m. given every 28 days for at least 2 months before the start of the Last Sandostatin LAR Dose Assessment Phase (Day -28) Inclusion criteria for patients with NETs; 1.Patients from whom written informed consent to participate in the study has been obtained prior to any screening procedures. 2.Male or female patients =18 years of age. 3.Patients with functional, well-differentiated (G1 or G2) neuroendocrine tumour (NET) with symptoms of carcinoid (bowel movements and/or flushing). 4.Patients currently receiving medical treatment with Sandostatin LAR (also Longastatina LAR for Italy) for symptom control at stable doses of 10 mg, 20 mg or 30 mg i.m. given every 28 days for at least 2 months before the start of the Last Sandostatin LAR Dose Assessment Phase (Day -28). 5.Patients with controlled symptoms, i.e., who do not require rescue medication with Sandostatin IR s.c. during Screening. 6.Patients not on treatment with any other agents for the treatment of NET (e.g., interferon, chemotherapy, radiotherapy, targeted agents). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients with Acromegaly: 1.Patients with inadequate bone marrow function as determined by WBC 2.0 × ULN, or serum albumin 450 msec for males, and QTcF >460 msec for females, and patients with sustained or clinically significant cardiac arrhythmias. 5.Patients with risk factors for Torsades de Pointes such as hypokalaemia, hypocalcaemia and hypomagnesemia, cardiac failure, clinically significant/ symptomatic bradycardia, and taking concomitant medication(s) known to prolong the QT interval. 6.Patients with impaired renal function as determined by serum creatinine >1.5 x ULN at screening. 7.Diabetic patients whose blood glucose is poorly controlled despite adequate therapy, as evidenced by glycosylated haemoglobin (HbA1C) >8.0% at screening. 8.Patients who require a surgical intervention for relief of any sign or symptom associated with tumour compression. Patients with compression of the optic chiasm causing acute clinically significant visual field defects. 9.Patients who have undergone major surgery/surgical therapy within 2 months before screening, or patients who are scheduled for any surgery within 6 months of starting this study. 10.Patients with active malignant disease within the last 5 years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix). Exclusion criteria for patients with NET: 1.Patients with 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. 2.Patients with carcinoid syndrome refractory to treatment with conventional doses of SSAs. 3.Patients with inadequate bone marrow function as determined by ANC 2 × upper limit of normal (ULN) without liver metastases, or > 5 x ULN if documented liver metastases; total serum bilirubin >2.0 × ULN, or serum albumin 450 msec for males, and QTcF >460 msec for females, and patients with sustained or clinically significant cardiac arrhythmias. 7.Patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterise the PK profile of octreotide after each injection of CAM2029 as compared with baseline PK Sandostatin® LAR® in patients with acromegaly and NETs ;Secondary Objective: The secondary objectives in patients with acromegaly are as follows: •To assess the safety and tolerability of CAM2029 •To compare the effect of treatment and exposure with CAM2029 on the response rate of insulin-like growth factor 1 (IGF-1) at Day 84 with baseline treatment with Sandostatin LAR, ie, normalisation of IGF-1 adjusted for age and gender •To compare the effect of treatment and exposure with CAM2029 on the reduction of mean growth hormone (GH) level to less than 2.5 µg/L at Day 84 with baseline treatment with Sandostatin LAR •To characterise IGF-1 profiles after treatment with CAM2029 as compared with baseline treatment with Sandostatin LAR •To compare the proportions of patients who have normalised GH and IGF-1 levels at Day 84 with baseline treatment with Sandostatin LAR The secondary objectives in patients with NETs are as follows: •To assess the safety and tolerability of CAM2029 ;Primary end point(s): PK. The following variables are considered primary PK variables: AUC0-28d, Ctrough, and Cmax of octreotide.;Timepoint(s) of evaluation of this end point: Continuously throughout the study, see protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety endpoints (all patients): •Incidence of treatment emergent AEs, including systemic tolerability and local tolerability (erythema, swelling, and pain) •Changes in vital sign measurements (pulse rate, systolic and diastolic blood pressure, and body temperature), clinical laboratory investigations (haematology, coagulation tests, biochemistry, , endocrinology, and pregnancy test), and physical examination findings •ECG results (ECGs to be analysed centrally •ECG analysis based on QT and corrected QT according to Fridericia’s formula (QTcF) (treatment-emergent QTcF >450 msec, >480 msec, and >500 msec and change from baseline >30 msec and >60 msec) •Results of the ultrasound examination of gallbladder Efficacy endpoints for patients with acromegaly: •Response rate of IGF-1 i.e. normalisation of IGF-1 (adjusted for age and gender) at baseline and at Day 84 •Proportion of patients with Reduction of mean GH level <2.5µg/L at baseline and at Day 84 •Change from baseline of IGF-1 and GH levels and maximum inhibition and AUC over 28 days of IGF-1 and GH levels •Proportion of patients who have normalised GH and IGF-1 levels 1 (adjusted for age and gender) at baseline and at Day 84 Exploratory endpoint for patients with acromegaly: •Octreotide concentration vs IGF-1 and GH modeling Exploratory endpoints for patients with NETs: •Symptoms of Carcinoid syndrome (bowel movements, flushing) with CAM2029 and Sandostatin LAR. •Use of rescue medication;Timepoint(s) of evaluation of this end point: Continuously throughout the study, see protocol | — |
Countries
Germany, Italy
Contacts
Public ContactClinical Programme Management
Camurus AB
Outcome results
None listed