Acromegaly, Neuroendocrine Tumors
Conditions
Keywords
acromegaly, neuroendocrine tumour (NET), carcinoid syndrome, octreotide, Sandostatin LAR
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-differentiated NET, with carcinoid symptoms.
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-differentiated NET, with carcinoid symptoms, treated for at least 2 months with Sandostatin LAR at doses of 10 mg, 20 mg, or 30 mg before the start of the Sandostatin LAR Last Dose Assessment Phase (Day -28).
Interventions
DRUGoctreotide FluidCrystal® injection depot
Sponsors
Novartis
Camurus AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days) | Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL) |
| Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) | Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR. |
| Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days) | Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals |
| Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) | Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for the final (Sandostatin LAR) dosing interval (ng/mL). |
| Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) | Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events and Serious Adverse Events | Day -28 to Day 84 | Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0) |
| CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) | Day 84 | Data is presented as number of patients * Within the reference limits (see below) * Above ULN (Upper Limits of Normal) In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below. REFERENCE VALUES Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years) Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years) |
| CAM2029 Effect on Growth Hormone (GH) (Acromegaly) | Day 84 | GH (growth hormone) levels measured on Day 84 in patients with acromegaly |
Other
| Measure | Time frame | Description |
|---|---|---|
| To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET) | Baseline (Day 0), Day 84 | Number of bowel movements and flushing during period 0 and 1, data is presented as patients experience symptoms Bowel movement without flushing Bowel movement and flushing No Bowel movement or Flushing |
Countries
France, Germany, Italy, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CAM2029 10 mg q2w (Acromegaly) CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot | 3 |
| CAM2029 20 mg q4w (Acromegaly) CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot | 4 |
| CAM2029 10 mg q2w (NET) CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot | 1 |
| CAM2029 20 mg q4w (NET) CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot | 4 |
| Total | 12 |
Baseline characteristics
| Characteristic | CAM2029 10 mg q2w (Acromegaly) | CAM2029 10 mg q2w (NET) | CAM2029 20 mg q4w (NET) | Total | CAM2029 20 mg q4w (Acromegaly) |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 2 Participants | 6 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants | 6 Participants | 2 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 14.93 | 59 years STANDARD_DEVIATION 0 | 64.8 years STANDARD_DEVIATION 4.11 | 62.1 years STANDARD_DEVIATION 7.59 | 62.5 years STANDARD_DEVIATION 4.8 |
| Region of Enrollment France | 1 participants | 0 participants | 1 participants | 5 participants | 3 participants |
| Region of Enrollment Germany | 0 participants | 1 participants | 3 participants | 4 participants | 0 participants |
| Region of Enrollment Italy | 2 participants | 0 participants | 0 participants | 3 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 4 Participants | 9 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 3 | 4 / 4 | 0 / 1 | 2 / 4 | 4 / 7 | 2 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 1 | 1 / 4 | 0 / 7 | 0 / 5 |
Outcome results
Primary
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC
Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR.
Time frame: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
Population: Pharmacokinetic population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC | 6.23 day*ng/mL | — |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC | 24.1 day*ng/mL | Standard Deviation 11.6 |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC | 27.8 day*ng/mL | — |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC | 39.9 day*ng/mL | Standard Deviation 20.5 |
Primary
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals
Time frame: (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
Population: Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 56 | 95.6 day*ng/mL | Standard Deviation 63.3 |
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 0 | 92.9 day*ng/mL | Standard Deviation 36.8 |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 0 | 72.4 day*ng/mL | Standard Deviation 6.73 |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 56 | 78.5 day*ng/mL | Standard Deviation 20 |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 56 | 83.3 day*ng/mL | — |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 0 | 72.9 day*ng/mL | — |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 56 | 135 day*ng/mL | Standard Deviation 34.7 |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC. | AUC0-28d (day*ng/mL) Day 0 | 135 day*ng/mL | Standard Deviation 37.8 |
Primary
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax
Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL)
Time frame: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
Population: Pharmacokinetic population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax | 0.349 ng/mL | — |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax | 1.41 ng/mL | Standard Deviation 0.693 |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax | 1.68 ng/mL | — |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax | 2.48 ng/mL | Standard Deviation 1.79 |
Primary
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.
Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)
Time frame: (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
Population: Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 0 | 10.4 ng/mL | Standard Deviation 6.62 |
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 56 | 10.6 ng/mL | Standard Deviation 10.2 |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 56 | 11.3 ng/mL | Standard Deviation 2.58 |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 0 | 13.4 ng/mL | Standard Deviation 4.31 |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 0 | 6.33 ng/mL | — |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 56 | 5.61 ng/mL | — |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 0 | 16.3 ng/mL | Standard Deviation 8.67 |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax. | Cmax (ng/mL) Day 56 | 15.7 ng/mL | Standard Deviation 4.05 |
Primary
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)
Time frame: (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
Population: Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng/mL) Day 0 | 1.32 ng/ml | Standard Deviation 0.422 |
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng(mL) Day 56 | 1.03 ng/ml | Standard Deviation 0.223 |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng(mL) Day 56 | 1.01 ng/ml | Standard Deviation 0.365 |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng/mL) Day 0 | 0.403 ng/ml | Standard Deviation 0.342 |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng/mL) Day 0 | 1.80 ng/ml | — |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng(mL) Day 56 | 1.27 ng/ml | — |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng/mL) Day 0 | 1.81 ng/ml | Standard Deviation 0.817 |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | Ctrough (ng(mL) Day 56 | 1.73 ng/ml | Standard Deviation 0.965 |
Primary
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for the final (Sandostatin LAR) dosing interval (ng/mL).
Time frame: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
Population: Pharmacokinetic population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | 0.225 ng/mL | — |
| Sandostatin LAR 30mg (Acromegaly) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | 1.20 ng/mL | Standard Deviation 0.647 |
| Sandostatin LAR 20 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | 0.901 ng/mL | — |
| Sandostatin LAR 30 mg (NET) | Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough | 1.27 ng/mL | Standard Deviation 0.48 |
Secondary
CAM2029 Effect on Growth Hormone (GH) (Acromegaly)
GH (growth hormone) levels measured on Day 84 in patients with acromegaly
Time frame: Day 84
Population: Pharmacokinetic population (5 acromegaly patients)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | CAM2029 Effect on Growth Hormone (GH) (Acromegaly) | GH level < 2.5 μg/L | 2 participants |
| Sandostatin LAR 10 mg (Acromegaly) | CAM2029 Effect on Growth Hormone (GH) (Acromegaly) | GH level >2.5 μg/L | 1 participants |
| Sandostatin LAR 30mg (Acromegaly) | CAM2029 Effect on Growth Hormone (GH) (Acromegaly) | GH level < 2.5 μg/L | 2 participants |
| Sandostatin LAR 30mg (Acromegaly) | CAM2029 Effect on Growth Hormone (GH) (Acromegaly) | GH level >2.5 μg/L | 0 participants |
Secondary
CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
Data is presented as number of patients * Within the reference limits (see below) * Above ULN (Upper Limits of Normal) In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below. REFERENCE VALUES Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years) Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)
Time frame: Day 84
Population: Pharmacokinetic population (5 acromegaly subjects total)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) | Within Normal Limits | 2 participants |
| Sandostatin LAR 10 mg (Acromegaly) | CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) | Above ULN | 1 participants |
| Sandostatin LAR 30mg (Acromegaly) | CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) | Within Normal Limits | 1 participants |
| Sandostatin LAR 30mg (Acromegaly) | CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) | Above ULN | 1 participants |
Secondary
Number of Adverse Events and Serious Adverse Events
Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0)
Time frame: Day -28 to Day 84
Population: Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | Number of Adverse Events and Serious Adverse Events | 2 Participants |
| Sandostatin LAR 30mg (Acromegaly) | Number of Adverse Events and Serious Adverse Events | 4 Participants |
| Sandostatin LAR 20 mg (NET) | Number of Adverse Events and Serious Adverse Events | 0 Participants |
| Sandostatin LAR 30 mg (NET) | Number of Adverse Events and Serious Adverse Events | 2 Participants |
| Sandostatin LAR (Acromegaly) | Number of Adverse Events and Serious Adverse Events | 4 Participants |
| Sandostain LAR (NET) | Number of Adverse Events and Serious Adverse Events | 2 Participants |
Other Pre-specified
To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)
Number of bowel movements and flushing during period 0 and 1, data is presented as patients experience symptoms Bowel movement without flushing Bowel movement and flushing No Bowel movement or Flushing
Time frame: Baseline (Day 0), Day 84
Population: Pharmacokinetic population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sandostatin LAR 10 mg (Acromegaly) | To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET) | Bowel movements without flushing | 1 participants |
| Sandostatin LAR 10 mg (Acromegaly) | To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET) | Bowel movements with flushing | 0 participants |
| Sandostatin LAR 10 mg (Acromegaly) | To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET) | No Bowel movement or Flushing | 0 participants |
| Sandostatin LAR 30mg (Acromegaly) | To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET) | Bowel movements without flushing | 0 participants |
| Sandostatin LAR 30mg (Acromegaly) | To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET) | Bowel movements with flushing | 2 participants |
| Sandostatin LAR 30mg (Acromegaly) | To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET) | No Bowel movement or Flushing | 2 participants |