Phase II Study of Subcutaneous Injection Depot of Octreotide in Patients With Acromegaly and Ne uroe ndocrine Tumours (NETs)

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1 A service of the U.S. National Institutes of Health Trial record 1 of 4 for: CAMURUS Previous Study Return to List Next Study Phase II Study of Subcutaneous Injection Depot of Octreotide in Patients With Acromegaly and Ne uroe ndocrine Tumours (NETs) This study is currently recruiting participants. (see Contacts and Locations) Verified July 2015 by Camurus AB Sponsor: Camurus AB Collaborator: Novartis ClinicalTrials.gov Identifier: NCT First received: November 17, 2014 Last updated: July 3, 2015 Last verified: July 2015 History of Changes Information prov ided by (Responsible Party): Camurus AB Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record Purpose This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of tw o dosing regimens of CAM2029 in adult patients w ith acromegaly or a functional, w ell-differentiated NET, w ith carcinoid symptoms, treated for at least 2 months w ith 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). Condition Interv ention Phase Acromegaly Neuroendocrine Tumors Phase 2 Study Type: Study Design: Official Title: Interventional Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment A Phase II, Open-label, Multicentre, Randomised Study of the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of CAM2029 in Tw o Patient Groups With Acromegaly and Neuroendocrine Tumours (NETs) Previously Treated With Sandostatin LAR Resource links prov ided by NLM: MedlinePlus related topics: Cancer Carcinoid Tumors Drug Information available for: Octreotide acetate Octreotide Genetic and Rare Diseases Information Center resources: APUDoma Acromegaly Carcinoid Syndrome Carcinoid Tumor Neuroepithelioma U.S. FDA Resources Further study details as prov ided by Camurus AB:

2 Primary Outcome Measures: Pharmacokinetic (PK) profile of octreotide after each injection of CAM2029 as compared w ith baseline PK for Sandostatin Long-acting Release (LAR ) [ Time Frame: Baseline, Day 84 ] [ Designated as safety issue: No ] Secondary Outcome Measures: Number of adverse events and serious adverse events [ Time Frame: Baseline, Day 84 ] [ Designated as safety issue: Yes ] Safety of repeat dose of CAM2029 CAM2029 effect on insulin-like grow th factor (IGF-1) (Acromegaly) [ Time Frame: Baseline, Day 84 ] [ Designated as safety issue: No ] CAM2029 effect on grow th hormone (GH) (Acromegaly) [ Time Frame: Baseline, Day 84 ] [ Designated as safety issue: No ] Other Outcome Measures: To assess the symptoms of carcinoid syndrome (number of bow el movements and flushing) and the use of rescue medication versus baseline (by using patient diaries) (NET) [ Time Frame: Baseline, Day 84 ] [ Designated as safety issue: No ] Estimated Enrollment: 24 Study Start Date: January 2015 Estimated Study Completion Date: January 2016 Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure) Arms Experimental: CAM mg (NET) CAM2029 (octreotide FluidCrystal injection ) 10 mg, subcutaneous injection every tw o w eeks Experimental: CAM mg (NET) CAM2029 (octreotide FluidCrystal injection ) 20 mg, subcutaneous injection once monthly Experimental: CAM mg (Acromegaly) CAM2029 (octreotide FluidCrystal injection ) 10 mg, subcutaneous injection every tw o w eeks Experimental: CAM mg (Acromegaly) CAM2029 (octreotide FluidCrystal injection ) 20 mg, subcutaneous injection once monthly Assigned Interv entions Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Both No Criteria Inclusion Criteria: Acromegaly: NET: Male or female patients 18 years of age Acromegaly currently treated w ith Sandostatin LAR Male or female patients 18 years of age Functional, w ell-differentiated (Grade 1 or Grade 2) NET w ith symptoms of carcinoid syndrome (number of bow el movements and/or flushing) Currently treated w ith Sandostatin LAR for symptom control Exclusion Criteria: Acromegaly: Inadequate bone marrow function Abnormal coagulation or chronic treatment w ith w arfarin or coumarin derivates

3 NET: Impaired liver, cardiac and/or renal function Know n gallbladder, bile duct disease or pancreatitis Diabetes w ith poorly controlled blood glucose levels despite adequate therapy Hypothyroidisms not adequately treated 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 w ith conventional doses of somatostatin analogues (SSAs) Inadequate bone marrow function Abnormal coagulation or chronic treatment w ith w arfarin or coumarin derivates Impaired liver, cardiac and/or renal function Know n gallbladder, bile duct disease or pancreatitis Short-bow el syndrome Diabetics w ith poorly controlled blood glucose levels despite adequate therapy Hypothyroidism, not adequately treated Contacts and Locations Choosing to participate in a study is an important personal decision. Talk w ith your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. Please refer to this study by its ClinicalTrials.gov identifier: NCT Contacts Contact: Håkan Olsson, Clin Dir hakan.olsson@cam urus.com Locations France Hospices Civils de Lyon Bron, France Contact: Borson-Chazot, Dr CHU Rouen, Hôpital Charles Nicolle Rouen cedex, France Contact: Cailleux, Dr Germany Abteilung: Klinische Studien Bad Berka, Germany Contact: Hoersch, Dr Charité Campus Virchow Klinikum Berlin, Germany Contact: Pavel, Prof Universitätsklinikum Essen Essen, Germany Contact: Lahner, Dr University Hospital of Freiburg Freiburg, Germany Contact: Seufert, Dr Medizinische Klinik und Poliklinik IV München, Germany Contact: Schopohl, Dr Italy I.R.C.C.S. Ospedale Oncologico "Giovanni Paolo II" di Bari Bari, Italy

4 Contact: Guida, Dr Azienda Ospedaliero-Universitaria Careggi Firenze, Italy Contact: Brand, Dr RCCS Azienda Ospedaliera Universitaria San Martino IST Genova, Italy Contact: Ferone, Dr Fondazione Irccs Ca' Granda Milano, Italy Contact: Mantovani, Dr Università degli Studi di Napoli Federico II Napoli, Italy Contact: Pivonello, Dr Istituto Regina Elena Rome, Italy Contact: Baldelli, Dr Istituto Clinico Humanitas Rozzano, Italy Contact: Lania, Dr Sw eden Göteborgs Universitet Göteborg, Sw eden Contact: Johannsson, Dr Karolinska Universitetssjukhuset Stockholm, Sw eden Contact: Höybye, Dr Akademiska sjukhuset Uppsala, Sw eden Contact: Engström, Dr Akademiska sjukhuset Uppsala, Sw eden Contact: Welin, Dr Sponsors and Collaborators Cam urus AB Novartis Inv estigators Principal Investigator: Marianne Pavel, Professor Charité Campus Virchow Klinikum, Berlin, Germany More Information No publications provided Responsible Party: Camurus AB ClinicalTrials.gov Identifier: NCT History of Changes Other Study ID Numbers: HS Study First Received: November 17, 2014 Last Updated: July 3, 2015 Health Authority: Sw eden: Medical Products Agency Italy: The Italian Medicines Agency France: Agence Nationale de Sécurité du Médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Keyw ords provided by Camurus AB: acromegaly neuroendocrine tumour (NET) carcinoid syndrome octreotide Sandostatin LAR

5 Additional relevant MeSH terms: Acromegaly Apudoma Carcinoid Tumor Neuroendocrine Tumors Adenocarcinoma Adenoma Bone Diseases Bone Diseases, Endocrine Brain Diseases Carcinoma Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Nervous System Diseases Neuroectodermal Tumors Pituitary Diseases Octreotide Antineoplastic Agents Antineoplastic Agents, Hormonal Gastrointestinal Agents Pharmacologic Actions Therapeutic Uses ClinicalTrials.gov processed this record on September 03, 2015

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A service of the U.S. National Institutes of Health Trial record 1 of 1 for: ASP 2215-cl-0101 Previous Study Return to List Next Study Dose Escalation Study Inv e stigating the Safe ty, Tole rability,