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Octreotide

Antineoplastic Agents, Hormonal

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

octreotide FluidCrystal® injection depot

Marianne Pavel, Professor

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.

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).

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®

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

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.

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

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).

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)

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)

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)

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)

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)

GH (growth hormone) levels measured on Day 84 in patients with acromegaly

Novartis

Camurus AB

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks

octreotide FluidCrystal® injection depot Day 0-84

CAM2029 10 mg q2w (Acromegaly)

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

octreotide FluidCrystal® injection depot Day 0-84

CAM2029 20 mg q4w (Acormegaly)

CAM2029 10 mg q2w (NET)

CAM2029 20 mg q4w (NET)

Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups

Sandostatin LAR (Acromegaly)

Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups

Sandostatin LAR (NET)

CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks

octreotide FluidCrystal® injection depot

CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

octreotide FluidCrystal® injection depot

CAM2029 20 mg q4w (Acromegaly)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Italy

France

Germany

Region of Enrollment

Clinical Trial Manager

Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR

Sandostatin LAR 10 mg (Acromegaly)

Sandostatin LAR 30mg (Acromegaly)

Sandostatin LAR 20 mg (NET)

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

AUC0-28d (day*ng/mL) Day 56

Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax

Ctrough (ng/mL) Day 0

Ctrough (ng(mL) Day 56

Cmax (ng/mL) Day 0

Cmax (ng/mL) Day 56

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.

Period day -28 to day 0 All acromegaly patients and all treatment groups

Period day-28 to 0 All NET patient and all treatment groups

Sandostain LAR (NET)

Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84)

Number of Adverse Events and Serious Adverse Events

Within Normal Limits

Above ULN

Pharmacokinetic population (5 acromegaly subjects total)

CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)

GH level < 2.5 μg/L

GH level >2.5 μg/L

Pharmacokinetic population (5 acromegaly patients)

CAM2029 Effect on Growth Hormone (GH) (Acromegaly)

Bowel movements without flushing

Bowel movements with flushing

No Bowel movement or Flushing

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)	NCT02299089	Acromegaly Neuroendocrine ...	octreotide Flui...	18 Years -	Camurus AB
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)	NCT02299089	Acromegaly Neuroendocrine ...	octreotide Flui...	18 Years -	Camurus AB

Spots Global Cancer Trial Database for neuroendocrine tumour (net)