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

Primary Purpose

Acromegaly, Neuroendocrine Tumors

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
octreotide FluidCrystal® injection depot
Sponsored by
Camurus AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acromegaly focused on measuring acromegaly, neuroendocrine tumour (NET), carcinoid syndrome, octreotide, Sandostatin LAR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospices Civils de Lyon
  • CHU Rouen, Hôpital Charles Nicolle
  • Abteilung: Klinische Studien
  • Charité Campus Virchow Klinikum
  • Universitätsklinikum Essen
  • RCCS Azienda Ospedaliera Universitaria San Martino IST
  • Fondazione Irccs Ca' Granda
  • Università degli Studi di Napoli Federico II
  • Istituto Clinico Humanitas
  • Akademiska sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

CAM2029 10 mg (NET)

CAM2029 20 mg (NET)

CAM2029 10 mg (Acromegaly)

CAM2029 20 mg (Acromegaly)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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 (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 (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 (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 (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 (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)

Secondary Outcome Measures

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

Full Information

First Posted
November 17, 2014
Last Updated
May 16, 2017
Sponsor
Camurus AB
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02299089
Brief Title
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
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®
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Camurus AB
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Neuroendocrine Tumors
Keywords
acromegaly, neuroendocrine tumour (NET), carcinoid syndrome, octreotide, Sandostatin LAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAM2029 10 mg (NET)
Arm Type
Experimental
Arm Description
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
Arm Title
CAM2029 20 mg (NET)
Arm Type
Experimental
Arm Description
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
Arm Title
CAM2029 10 mg (Acromegaly)
Arm Type
Experimental
Arm Description
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
Arm Title
CAM2029 20 mg (Acromegaly)
Arm Type
Experimental
Arm Description
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
Intervention Type
Drug
Intervention Name(s)
octreotide FluidCrystal® injection depot
Other Intervention Name(s)
CAM2029
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC
Description
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)
Title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
Description
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)
Title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
Description
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)
Title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax
Description
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)
Title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
Description
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)
Title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.
Description
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 Outcome Measure Information:
Title
Number of Adverse Events and Serious Adverse Events
Description
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
Title
CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
Description
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
Title
CAM2029 Effect on Growth Hormone (GH) (Acromegaly)
Description
GH (growth hormone) levels measured on Day 84 in patients with acromegaly
Time Frame
Day 84
Other Pre-specified Outcome Measures:
Title
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)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Pavel, Professor
Organizational Affiliation
Charité Campus Virchow Klinikum, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
Country
France
Facility Name
CHU Rouen, Hôpital Charles Nicolle
City
Rouen cedex
Country
France
Facility Name
Abteilung: Klinische Studien
City
Bad Berka
Country
Germany
Facility Name
Charité Campus Virchow Klinikum
City
Berlin
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
RCCS Azienda Ospedaliera Universitaria San Martino IST
City
Genova
Country
Italy
Facility Name
Fondazione Irccs Ca' Granda
City
Milano
Country
Italy
Facility Name
Università degli Studi di Napoli Federico II
City
Napoli
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
Country
Italy
Facility Name
Akademiska sjukhuset
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Citations:
PubMed Identifier
30535537
Citation
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.
Results Reference
derived

Learn more about this trial

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

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