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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAM2029 10 mg (NET) | Experimental | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks |
|
| CAM2029 20 mg (NET) | Experimental | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly |
|
| CAM2029 10 mg (Acromegaly) | Experimental | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks |
|
| CAM2029 20 mg (Acromegaly) | Experimental | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| octreotide FluidCrystal® injection depot | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) |
| 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 | (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) |
| 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). | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) |
| Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day -28 to Day 84 |
| CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (Day 0), Day 84 |
Inclusion Criteria:
Acromegaly:
NET:
Exclusion Criteria:
Acromegaly:
NET:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Pavel, Professor | Charité Campus Virchow Klinikum, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Bron | France | ||||
| CHU Rouen, Hôpital Charles Nicolle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30535537 | Derived | Pavel M, Borson-Chazot F, Cailleux A, Horsch D, Lahner H, Pivonello R, Tauchmanova L, Darstein C, Olsson H, Tiberg F, Ferone D. Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study. Cancer Chemother Pharmacol. 2019 Feb;83(2):375-385. doi: 10.1007/s00280-018-3734-1. Epub 2018 Dec 8. |
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No plan to share IPD
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| ID | Title | Description |
|---|---|---|
| FG000 | CAM2029 10 mg q2w (Acromegaly) | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot |
| FG001 | CAM2029 20 mg q4w (Acromegaly) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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) |
| Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) |
| 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) | (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) |
| 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) | (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) |
Data is presented as number of patients
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) |
| Day 84 |
| CAM2029 Effect on Growth Hormone (GH) (Acromegaly) | GH (growth hormone) levels measured on Day 84 in patients with acromegaly | Day 84 |
| Rouen |
| France |
| Abteilung: Klinische Studien | Bad Berka | Germany |
| Charité Campus Virchow Klinikum | Berlin | Germany |
| Universitätsklinikum Essen | Essen | Germany |
| RCCS Azienda Ospedaliera Universitaria San Martino IST | Genova | Italy |
| Fondazione Irccs Ca' Granda | Milan | Italy |
| Università degli Studi di Napoli Federico II | Naples | Italy |
| Istituto Clinico Humanitas | Rozzano | Italy |
| Akademiska sjukhuset | Uppsala | Sweden |
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot
| FG002 | CAM2029 10 mg q2w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot |
| FG003 | CAM2029 20 mg q4w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CAM2029 10 mg q2w (Acromegaly) | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot |
| BG001 | CAM2029 20 mg q4w (Acromegaly) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot |
| BG002 | CAM2029 10 mg q2w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot |
| BG003 | CAM2029 20 mg q4w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Pharmacokinetic population | Posted | Mean | Standard Deviation | day*ng/mL | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) |
|
|
| ||||||||||||||||||||||||||||||||||
| 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 | Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose. | Posted | Mean | Standard Deviation | day*ng/mL | (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) |
| ||||||||||||||||||||||||||||||||||||
| 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). | Pharmacokinetic population | Posted | Mean | Standard Deviation | ng/mL | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) |
| ||||||||||||||||||||||||||||||||||||
| 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) | Pharmacokinetic population | Posted | Mean | Standard Deviation | ng/mL | Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days) |
| ||||||||||||||||||||||||||||||||||||
| 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) | Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose. | Posted | Mean | Standard Deviation | ng/ml | (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) |
| ||||||||||||||||||||||||||||||||||||
| 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) | Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose. | Posted | Mean | Standard Deviation | ng/mL | (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) |
| ||||||||||||||||||||||||||||||||||||
| 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) | Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84) | Posted | Count of Participants | Participants | Day -28 to Day 84 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) | Data is presented as number of patients
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) | Pharmacokinetic population (5 acromegaly subjects total) | Posted | Number | participants | Day 84 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | CAM2029 Effect on Growth Hormone (GH) (Acromegaly) | GH (growth hormone) levels measured on Day 84 in patients with acromegaly | Pharmacokinetic population (5 acromegaly patients) | Posted | Number | participants | Day 84 |
|
| ||||||||||||||||||||||||||||||||||||
| 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 | Pharmacokinetic population | Posted | Number | participants | Baseline (Day 0), Day 84 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAM2029 10 mg q2w (Acromegaly) | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot Day 0-84 | 0 | 3 | 2 | 3 | ||
| EG001 | CAM2029 20 mg q4w (Acormegaly) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot Day 0-84 | 0 | 4 | 4 | 4 | ||
| EG002 | CAM2029 10 mg q2w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot Day 0-84 | 0 | 1 | 0 | 1 | ||
| EG003 | CAM2029 20 mg q4w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot Day 0-84 | 1 | 4 | 2 | 4 | ||
| EG004 | Sandostatin LAR (Acromegaly) | Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups | 0 | 7 | 4 | 7 | ||
| EG005 | Sandostatin LAR (NET) | Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups | 0 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anastomotic ulcer hemorrhage | Gastrointestinal disorders | MedDRAversion 16.0 | Non-systematic Assessment | D39, patient noticed intermittent episodes of blood in stools due to a ulceration of a previous anastomosis. Patient received the last injection dose D57 and was hospitalized for investigations of bleeding, resolved on D60, not related to treatment. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Eyelid disorder | Eye disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diverticulum Intestinal | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Weight decrease | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Decreased appetitie | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Insulin like growth factor increase | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Manager | Camurus AB | +46 46 2876 530 | Info@Camurus.com |
| ID | Term |
|---|---|
| D000172 | Acromegaly |
| D018358 | Neuroendocrine Tumors |
| D020230 | Serotonin Syndrome |
| ID | Term |
|---|---|
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| France |
|
| Germany |
|
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot |
| OG003 | CAM2029 20 mg q4w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot |
|
|
| OG003 | Sandostatin LAR 30 mg (NET) | Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR |
|
|
| OG003 | Sandostatin LAR 30 mg (NET) | Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR |
|
|
| OG003 | CAM2029 20 mg q4w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot |
|
|
| OG003 | CAM2029 20 mg q4w (NET) | CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot |
|
|
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot |
| OG004 | Sandostatin LAR (Acromegaly) | Period day -28 to day 0 All acromegaly patients and all treatment groups |
| OG005 | Sandostain LAR (NET) | Period day-28 to 0 All NET patient and all treatment groups |
|
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| Participants |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|