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

NCT ID: NCT02299089

Last Updated: 2017-12-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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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

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Acromegaly Neuroendocrine Tumors

Keywords

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acromegaly neuroendocrine tumour (NET) carcinoid syndrome octreotide Sandostatin LAR

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAM2029 10 mg (NET)

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

Group Type EXPERIMENTAL

octreotide FluidCrystal® injection depot

Intervention Type DRUG

CAM2029 20 mg (NET)

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

Group Type EXPERIMENTAL

octreotide FluidCrystal® injection depot

Intervention Type DRUG

CAM2029 10 mg (Acromegaly)

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

Group Type EXPERIMENTAL

octreotide FluidCrystal® injection depot

Intervention Type DRUG

CAM2029 20 mg (Acromegaly)

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

Group Type EXPERIMENTAL

octreotide FluidCrystal® injection depot

Intervention Type DRUG

Interventions

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octreotide FluidCrystal® injection depot

Intervention Type DRUG

Other Intervention Names

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CAM2029

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Camurus AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Pavel, Professor

Role: PRINCIPAL_INVESTIGATOR

Charité Campus Virchow Klinikum, Berlin, Germany

Locations

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Hospices Civils de Lyon

Bron, , France

Site Status

CHU Rouen, Hôpital Charles Nicolle

Rouen, , France

Site Status

Abteilung: Klinische Studien

Bad Berka, , Germany

Site Status

Charité Campus Virchow Klinikum

Berlin, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

RCCS Azienda Ospedaliera Universitaria San Martino IST

Genova, , Italy

Site Status

Fondazione Irccs Ca' Granda

Milan, , Italy

Site Status

Università degli Studi di Napoli Federico II

Napoli, , Italy

Site Status

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

Akademiska sjukhuset

Uppsala, , Sweden

Site Status

Countries

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France Germany Italy Sweden

References

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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.

Reference Type DERIVED
PMID: 30535537 (View on PubMed)

Other Identifiers

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HS-12-455

Identifier Type: -

Identifier Source: org_study_id