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

NCT02299089 | Completed Phase 2 Results

• 1 other identifier: HS-12-455
• Study Type: interventional
• Target: 12
• Locations: 4 countries
• Sites: 10

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.

Conditions

Acromegaly; Neuroendocrine Tumors

Keywords

acromegaly; neuroendocrine tumour (NET); carcinoid syndrome; octreotide; Sandostatin LAR

Outcome Measures

Primary Outcomes (6)

• 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

  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)

Secondary Outcomes (3)

• Number of Adverse Events and Serious Adverse Events

  Day -28 to Day 84

• CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)

  Day 84

• CAM2029 Effect on Growth Hormone (GH) (Acromegaly)

  Day 84

Other Outcomes (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)

  Baseline (Day 0), Day 84

Study Arms (4)

CAM2029 10 mg (NET)

EXPERIMENTAL

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

Drug: octreotide FluidCrystal® injection depot

CAM2029 20 mg (NET)

EXPERIMENTAL

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

Drug: octreotide FluidCrystal® injection depot

CAM2029 10 mg (Acromegaly)

EXPERIMENTAL

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

Drug: octreotide FluidCrystal® injection depot

CAM2029 20 mg (Acromegaly)

EXPERIMENTAL

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

Drug: octreotide FluidCrystal® injection depot

Interventions

octreotide FluidCrystal® injection depot DRUG

Also known as: CAM2029

CAM2029 10 mg (Acromegaly); CAM2029 10 mg (NET); CAM2029 20 mg (Acromegaly); CAM2029 20 mg (NET)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Camurus AB: lead
• Novartis: collaborator

Study Sites (10)

Hospices Civils de Lyon

Bron, France

Location

CHU Rouen, Hôpital Charles Nicolle

Rouen, France

Location

Abteilung: Klinische Studien

Bad Berka, Germany

Location

Charité Campus Virchow Klinikum

Berlin, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

RCCS Azienda Ospedaliera Universitaria San Martino IST

Genova, Italy

Location

Fondazione Irccs Ca' Granda

Milan, Italy

Location

Università degli Studi di Napoli Federico II

Napoli, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Akademiska sjukhuset

Uppsala, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30535537 DERIVED

MeSH Terms

Conditions

Acromegaly; Neuroendocrine Tumors; Serotonin Syndrome

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Camurus AB

Info@Camurus.com

+46 46 2876 530

Study Officials

• Marianne Pavel, Professor

  Charité Campus Virchow Klinikum, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 15, 2017
• Results First Posted: December 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); FR (2); DE (3); IT (4)