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

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ClinicalTrials.gov Identifier: NCT02299089
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : December 15, 2017
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Camurus AB

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.

Condition or disease Intervention/treatment Phase
Acromegaly Neuroendocrine Tumors Drug: octreotide FluidCrystal® injection depot Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016


Arm Intervention/treatment
Experimental: CAM2029 10 mg (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
Drug: octreotide FluidCrystal® injection depot
Other Name: CAM2029

Experimental: CAM2029 20 mg (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
Drug: octreotide FluidCrystal® injection depot
Other Name: CAM2029

Experimental: CAM2029 10 mg (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
Drug: octreotide FluidCrystal® injection depot
Other Name: CAM2029

Experimental: CAM2029 20 mg (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
Drug: octreotide FluidCrystal® injection depot
Other Name: CAM2029




Primary Outcome Measures :
  1. 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.


  2. 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


  3. 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).


  4. 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)


  5. 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)


  6. 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)



Secondary Outcome Measures :
  1. Number of Adverse Events and Serious Adverse Events [ Time Frame: Day -28 to Day 84 ]
    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)

  2. CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly) [ Time Frame: Day 84 ]

    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)


  3. CAM2029 Effect on Growth Hormone (GH) (Acromegaly) [ Time Frame: Day 84 ]
    GH (growth hormone) levels measured on Day 84 in patients with acromegaly


Other Outcome Measures:
  1. 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) [ Time Frame: Baseline (Day 0), Day 84 ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299089


Locations
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France
Hospices Civils de Lyon
Bron, France
CHU Rouen, Hôpital Charles Nicolle
Rouen cedex, France
Germany
Abteilung: Klinische Studien
Bad Berka, Germany
Charité Campus Virchow Klinikum
Berlin, Germany
Universitätsklinikum Essen
Essen, Germany
Italy
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
Sweden
Akademiska sjukhuset
Uppsala, Sweden
Sponsors and Collaborators
Camurus AB
Novartis
Investigators
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Principal Investigator: Marianne Pavel, Professor Charité Campus Virchow Klinikum, Berlin, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT02299089     History of Changes
Other Study ID Numbers: HS-12-455
First Posted: November 24, 2014    Key Record Dates
Results First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

Keywords provided by Camurus AB:
acromegaly
neuroendocrine tumour (NET)
carcinoid syndrome
octreotide
Sandostatin LAR

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Acromegaly
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents