CompletedNCT02299089Updated Dec 15, 2017Results posted

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

A Phase 2 interventional study of octreotide FluidCrystal® injection depot in Acromegaly and Neuroendocrine Tumors, sponsored by Camurus AB. Completed at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-15.

Sponsored by Camurus AB · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 12
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Read the 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).

Conditions studied

Acromegaly
Neuroendocrine Tumors

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Keywords

acromegaly
neuroendocrine tumour (NET)
carcinoid syndrome
octreotide
Sandostatin LAR

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's enrollment of 12 is below the median of 43 across 115 interventional studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Camurus AB is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory: Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 12 participants (actual)

Study arms

Experimental
CAM2029 10 mg (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
Drug: octreotide FluidCrystal® injection depot
Experimental
CAM2029 20 mg (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
Drug: octreotide FluidCrystal® injection depot
Experimental
CAM2029 10 mg (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
Drug: octreotide FluidCrystal® injection depot
Experimental
CAM2029 20 mg (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
Drug: octreotide FluidCrystal® injection depot

Interventions

Drugoctreotide FluidCrystal® injection depot
Drug pages: Octreotide hydrochloride · Octreotide Depot Formulation CAM2029
Also known as: CAM2029

What researchers measure

Primary outcomes

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)
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)
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)
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)
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)
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)

Secondary outcomes

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
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
CAM2029 Effect on Growth Hormone (GH) (Acromegaly)
GH (growth hormone) levels measured on Day 84 in patients with acromegaly
Time frame: Day 84

Other outcomes

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

Results

Posted Dec 15, 2017

Participant flow

Participant flow — Overall Study
Milestone	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)
Started	3	4	1	4
Completed	3	4	1	4
Not completed	0	0	0	0

Outcome measures

PrimaryPharmacokinetic (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)
Reported as:: Mean · day*ng/mL

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC
day*ng/mL	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	6.23 ± NA	24.1 ± 11.6	27.8 ± NA	39.9 ± 20.5

PrimaryPharmacokinetic (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)
Reported as:: Mean · day*ng/mL

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
day*ng/mL	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)
AUC0-28d (day*ng/mL) Day 0	92.9 ± 36.8	72.4 ± 6.73	72.9 ± NA	135 ± 37.8
AUC0-28d (day*ng/mL) Day 56	95.6 ± 63.3	78.5 ± 20.0	83.3 ± NA	135 ± 34.7

PrimaryPharmacokinetic (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)
Reported as:: Mean · ng/mL

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
ng/mL	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®) Ctrough	0.225 ± NA	1.20 ± 0.647	0.901 ± NA	1.27 ± 0.480

PrimaryPharmacokinetic (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)
Reported as:: Mean · ng/mL

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax
ng/mL	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®) Cmax	0.349 ± NA	1.41 ± 0.693	1.68 ± NA	2.48 ± 1.79

PrimaryPharmacokinetic (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)
Reported as:: Mean · ng/ml

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
ng/ml	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)
Ctrough (ng/mL) Day 0	1.32 ± 0.422	0.403 ± 0.342	1.80 ± NA	1.81 ± 0.817
Ctrough (ng(mL) Day 56	1.03 ± 0.223	1.01 ± 0.365	1.27 ± NA	1.73 ± 0.965

PrimaryPharmacokinetic (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)
Reported as:: Mean · ng/mL

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.
ng/mL	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)
Cmax (ng/mL) Day 0	10.4 ± 6.62	13.4 ± 4.31	6.33 ± NA	16.3 ± 8.67
Cmax (ng/mL) Day 56	10.6 ± 10.2	11.3 ± 2.58	5.61 ± NA	15.7 ± 4.05

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Adverse Events and Serious Adverse Events
Participants	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)	Sandostatin LAR (Acromegaly)	Sandostain LAR (NET)
Number of Adverse Events and Serious Adverse Events	2	4	0	2	4	2

SecondaryCAM2029 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
Reported as:: Number · participants

CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
participants	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)
Within Normal Limits	2	1
Above ULN	1	1

SecondaryCAM2029 Effect on Growth Hormone (GH) (Acromegaly)

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

Time frame:: Day 84
Reported as:: Number · participants

CAM2029 Effect on Growth Hormone (GH) (Acromegaly)
participants	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)
GH level < 2.5 μg/L	2	2
GH level >2.5 μg/L	1	0

Other pre-specifiedTo 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
Reported as:: Number · participants

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)
participants	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)
Bowel movements without flushing	1	0
Bowel movements with flushing	0	2
No Bowel movement or Flushing	0	2

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CAM2029 10 mg q2w (Acromegaly)	—	0/3 (0%)	2/3 (66.7%)
CAM2029 20 mg q4w (Acormegaly)	—	0/4 (0%)	4/4 (100%)
CAM2029 10 mg q2w (NET)	—	0/1 (0%)	0/1 (0%)
CAM2029 20 mg q4w (NET)	—	1/4 (25%)	2/4 (50%)
Sandostatin LAR (Acromegaly)	—	0/7 (0%)	4/7 (57.1%)
Sandostatin LAR (NET)	—	0/5 (0%)	2/5 (40%)

Most frequent serious events

Most frequent serious events
Event	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acormegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)	Sandostatin LAR (Acromegaly)	Sandostatin LAR (NET)
Anastomotic ulcer hemorrhageGastrointestinal disorders	0/3	0/4	0/1	1/4	0/7	0/5

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acormegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)	Sandostatin LAR (Acromegaly)	Sandostatin LAR (NET)
Injection site painGeneral disorders	0/3	2/4	0/1	1/4	0/7	0/5
DiarrhoeaGastrointestinal disorders	1/3	1/4	0/1	0/4	0/7	1/5
CoughRespiratory, thoracic and mediastinal disorders	1/3	0/4	0/1	0/4	0/7	0/5
VertigoEar and labyrinth disorders	0/3	1/4	0/1	0/4	0/7	0/5
Eyelid disorderEye disorders	0/3	1/4	0/1	0/4	0/7	0/5
Food poisoningGastrointestinal disorders	0/3	1/4	0/1	0/4	0/7	0/5
Diabetes MellitusMetabolism and nutrition disorders	0/3	1/4	0/1	1/4	0/7	0/5
ErythemaSkin and subcutaneous tissue disorders	0/3	1/4	0/1	0/4	0/7	0/5
Diverticulum IntestinalGastrointestinal disorders	0/3	0/4	0/1	1/4	0/7	0/5
HaematocheziaGastrointestinal disorders	0/3	0/4	0/1	1/4	0/7	0/5

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	1	2	1	2	6
>=65 years	2	2	0	2	6

Age, Continuous
Age, Continuous(years)	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)	Total
Mean	59 ± 14.93	62.5 ± 4.80	59 ± 0	64.8 ± 4.11	62.1 ± 7.59

Sex: Female, Male
Sex: Female, Male(Participants)	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)	Total
Female	1	2	0	0	3
Male	2	2	1	4	9

Region of Enrollment
Region of Enrollment(participants)	CAM2029 10 mg q2w (Acromegaly)	CAM2029 20 mg q4w (Acromegaly)	CAM2029 10 mg q2w (NET)	CAM2029 20 mg q4w (NET)	Total
Italy	2	1	0	0	3
France	1	3	0	1	5
Germany	0	0	1	3	4

Study locations

10 sites

Hospices Civils de Lyon
Bron, France
CHU Rouen, Hôpital Charles Nicolle
Rouen cedex, 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
Milano, Italy
Università degli Studi di Napoli Federico II
Napoli, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Akademiska sjukhuset
Uppsala, Sweden

References and documents

Publications

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. PubMed 30535537 ↗

Individual participant data

Plan to share: No — No plan to share IPD

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02299089
Lead sponsor: Camurus AB
Collaborators: Novartis
Responsible party: Sponsor
First posted: Nov 24, 2014
Start date: Jan 2015
Primary completion: May 2016
Completion: Jun 2016
Results posted: Dec 15, 2017
Last update: Dec 15, 2017

Study contacts

Marianne Pavel, Professor

principal investigator · Charité Campus Virchow Klinikum, Berlin, Germany

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Octreotide hydrochloride · Octreotide Depot Formulation CAM2029

Other studies in this condition

Acromegaly →

Other studies from this sponsor

Camurus AB

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