AcromegalyPhase 2NCT02299089

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

A Phase 2 study testing octreotide FluidCrystal® injection depot in people with Acromegaly and Neuroendocrine Tumors, run by Camurus AB at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acromegaly, Neuroendocrine Tumors
What is being tested?: octreotide FluidCrystal® injection depot
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 10 sitesin 4 countries
Study dates: Jan 2015to Jun 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 17Show fewer

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

Trial locations and contacts

10 sites in 4 countries.

Country

City, postcode or hospital

10 sites in 4 countries

Italy4 sites

RCCS Azienda Ospedaliera Universitaria San Martino IST
Genova
Fondazione Irccs Ca' Granda
Milan
Università degli Studi di Napoli Federico II
Naples
Istituto Clinico Humanitas
Rozzano

Other trials in Italy

Germany3 sites

Abteilung: Klinische Studien
Bad Berka
Charité Campus Virchow Klinikum
Berlin
Universitätsklinikum Essen
Essen

Other trials in Germany

France2 sites

Hospices Civils de Lyon
Bron
CHU Rouen, Hôpital Charles Nicolle
Rouen

Other trials in France

Sweden1 site

Akademiska sjukhuset
Uppsala

Other trials in Sweden

About this study

Official title: 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®

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: Acromegaly, Neuroendocrine Tumors
Being tested: octreotide FluidCrystal® injection depot
Keywords: acromegaly, neuroendocrine tumour (NET), carcinoid syndrome, octreotide, Sandostatin LAR
Medical subject headings: Acromegaly, Neuroendocrine Tumors, Serotonin Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

octreotide FluidCrystal® injection depotDrug
Also called CAM2029

Study groups in NCT02299089
Study group	Role	What they receive
CAM2029 10 mg (NET)	Experimental	CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks Receives: Drug: octreotide FluidCrystal® injection depot
CAM2029 20 mg (NET)	Experimental	CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly Receives: Drug: octreotide FluidCrystal® injection depot
CAM2029 10 mg (Acromegaly)	Experimental	CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks Receives: Drug: octreotide FluidCrystal® injection depot
CAM2029 20 mg (Acromegaly)	Experimental	CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly Receives: Drug: octreotide FluidCrystal® injection depot

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: (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).
Measured: 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)
Measured: 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)
Measured: (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)
Measured: (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 (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jun 2016

First posted24 Nov 2014 (estimated)
Study startJan 2015
Primary completionMay 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AcromegalyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02299089
Sponsor's protocol ID: HS-12-455
Status last verified: May 2017
First submitted: 17 Nov 2014
Last updated: 15 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: No plan to share IPD

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

All Acromegaly trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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®
ClinicalTrials.gov ID: NCT02299089
Acronym / sponsor ID: HS-12-455
Conditions: Acromegaly, Neuroendocrine Tumors
Keywords: acromegaly, neuroendocrine tumour (NET), carcinoid syndrome, octreotide, Sandostatin LAR
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Camurus ABIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Jan 2015
Primary completion: May 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 24 Nov 2014 (estimated)
Results: Posted 15 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
CAM2029 10 mg (NET)	Experimental	Drug: octreotide FluidCrystal® injection depotCAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
CAM2029 20 mg (NET)	Experimental	Drug: octreotide FluidCrystal® injection depotCAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
CAM2029 10 mg (Acromegaly)	Experimental	Drug: octreotide FluidCrystal® injection depotCAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
CAM2029 20 mg (Acromegaly)	Experimental	Drug: octreotide FluidCrystal® injection depotCAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female patients ≥18 years of age
Acromegaly currently treated with Sandostatin LAR
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

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
octreotide FluidCrystal® injection depotAlso: CAM2029	Drug	CAM2029 10 mg (Acromegaly), CAM2029 10 mg (NET), CAM2029 20 mg (Acromegaly), CAM2029 20 mg (NET)

Primary outcome

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

3 secondary outcomes

Number of Adverse Events and Serious Adverse Events
Time frame: Day -28 to Day 84
CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
Time frame: Day 84
CAM2029 Effect on Growth Hormone (GH) (Acromegaly)
Time frame: Day 84

Results and safety

Results posted to the registry on 15 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CAM2029 10 mg q2w (Acromegaly)	3	3
CAM2029 20 mg q4w (Acromegaly)	4	4
CAM2029 10 mg q2w (NET)	1	1
CAM2029 20 mg q4w (NET)	4	4

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

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). Mean (Standard Deviation). Unit: day*ng/mL

Measure	Sandostatin LAR 10 mg (Acromegaly) n = 1	Sandostatin LAR 30mg (Acromegaly) n = 4	Sandostatin LAR 20 mg (NET) n = 1	Sandostatin LAR 30 mg (NET) n = 4
Value	6.23 (NA)	24.1 (11.6)	27.8 (NA)	39.9 (20.5)

Population analysed: Pharmacokinetic population

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

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). Mean (Standard Deviation). Unit: day*ng/mL

Measure	CAM2029 10 mg q2w (Acromegaly) n = 3	CAM2029 20 mg q4w (Acromegaly) n = 2	CAM2029 10 mg q2w (NET) n = 1	CAM2029 20 mg q4w (NET) n = 4
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)

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

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

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). Mean (Standard Deviation). Unit: ng/mL

Measure	Sandostatin LAR 10 mg (Acromegaly) n = 1	Sandostatin LAR 30mg (Acromegaly) n = 4	Sandostatin LAR 20 mg (NET) n = 1	Sandostatin LAR 30 mg (NET) n = 3
Value	0.225 (NA)	1.20 (0.647)	0.901 (NA)	1.27 (0.480)

Population analysed: Pharmacokinetic population

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

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). Mean (Standard Deviation). Unit: ng/mL

Measure	Sandostatin LAR 10 mg (Acromegaly) n = 1	Sandostatin LAR 30mg (Acromegaly) n = 4	Sandostatin LAR 20 mg (NET) n = 1	Sandostatin LAR 30 mg (NET) n = 4
Value	0.349 (NA)	1.41 (0.693)	1.68 (NA)	2.48 (1.79)

Population analysed: Pharmacokinetic population

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CAM2029 10 mg q2w (Acromegaly)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
CAM2029 20 mg q4w (Acormegaly)	0 of 4 (0%)	4 of 4 (100%)	Not reported
CAM2029 10 mg q2w (NET)	0 of 1 (0%)	0 of 1 (0%)	Not reported
CAM2029 20 mg q4w (NET)	1 of 4 (25%)	2 of 4 (50%)	Not reported
Sandostatin LAR (Acromegaly)	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Sandostatin LAR (NET)	0 of 5 (0%)	2 of 5 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30535537Pavel 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.
Individual participant dataSharing planned: No. No plan to share IPD

Related trials for Acromegaly

RecruitingPhase 1
A Phase 1 Clinical Trial of NTQ6179 Tablets in Healthy Volunteers
Acromegaly
RecruitingObservational study
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
Acromegaly
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
Acromegaly
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
Panhypopituitarism, Gigantism/Acromegaly
Recruiting
Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
Acromegaly Due to Pituitary Adenoma, Hyperglycemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marianne Pavel, Professor principal investigator

Charité Campus Virchow Klinikum, Berlin, Germany

10 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing octreotide FluidCrystal® injection depot in people with Acromegaly and Neuroendocrine Tumors, run by Camurus AB at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Italy, Germany, France, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC (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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02299089, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.