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Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by ITM Solucin GmbH
Sponsor:
Collaborator:
ABX CRO
Information provided by (Responsible Party):
ITM Solucin GmbH
ClinicalTrials.gov Identifier:
NCT03049189
First received: January 13, 2017
Last updated: August 17, 2017
Last verified: August 2017
  Purpose
The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Condition Intervention Phase
Neuroendocrine Tumors Drug: 177Lu-edotreotide PRRT Drug: Everolimus Other: Amino-Acid Solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET)

Resource links provided by NLM:


Further study details as provided by ITM Solucin GmbH:

Primary Outcome Measures:
  • progression-free survival (PFS) [ Time Frame: 12 weeks +/- 14 days, up to 24 months ]
    PFS will be assessed individually per patient from date of randomization until the date of first documented progression, assessed up to 24 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days


Secondary Outcome Measures:
  • overall survival (OS) [ Time Frame: every 3 months for a period of at least 24 months ]
    OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first


Estimated Enrollment: 300
Actual Study Start Date: February 2, 2017
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 177Lu-edotreotide PRRT

177Lu-edotreotide (177Lu-DOTATOC)

A maximum of four cycles of 7.5 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)

Drug: 177Lu-edotreotide PRRT
PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
Other Names:
  • 177Lu-DOTATOC
  • 177Lu-Edo
Other: Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
Other Name: Arginine-Lysine Solution
Active Comparator: Everolimus

Everolimus (Afinitor ®)

Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)

Drug: Everolimus
Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
Other Name: Afinitor

  Eligibility

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

Inclusion Criteria:

  • Histologically and clinically confirmed diagnosis of well-differentiated neuro-endocrine tumour of non-functional gastroenteric origin (GE-NET) or both functional or non-functional pancreatic origin (P-NET)
  • Measurable disease per RECIST 1.1
  • Somatostatin receptor positive (SSTR+) disease
  • Radiological disease progression, defined as progressive disease per RECIST 1.1. criteria

Exclusion Criteria:

  • Known hypersensitivity to edotreotide or everolimus
  • Known hypersensitivity to DOTA, lutetium-177, or any excipient of edotreotide or everolimus
  • Prior exposure to any peptide receptor radionuclide therapy (PRRT)
  • Prior therapy with mTor inhibitors
  • Prior EFR (extended field radiation) to GEP-NET lesions or radioembolisation therapy
  • Therapy with an investigational compound and/or medical device within 30 days prior to randomisation
  • Indication for surgical lesion removal with curative potential
  • Planned alternative therapy (for the period of study participation)
  • Serious non-malignant disease
  • Renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the study treatments
  • Pregnant or breast-feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with 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: NCT03049189

Contacts
Contact: Konstantin Zhernosekov, Dr info@itm-solucin.de
Contact: Ulrike Schorr-Neufing, Dr info@abx-cro.com

Locations
Australia, New South Wales
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Australia, Victoria
Olivia Newton-John Cancer & Wellness Centre, Austin Hospital Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Austria
Allgemeines Krankenhaus Wien Not yet recruiting
Wien, Austria, 1090
France
Hospices civils de Lyon Not yet recruiting
Bron, France, 69677
HP Hôpital Beaujon Not yet recruiting
Clichy, France, 92110
Institut de Recherche en Cancérologie de Montpellier (IRCM) Not yet recruiting
Montpellier, France, 34298
CHU de Nantes - Hôtel Dieu Not yet recruiting
Nantes, France, 44093
Germany
Zentralklinik Bad Berka GmbH Not yet recruiting
Bad Berka, Germany, 99437
Charité - Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Universitätsklinikum Bonn Not yet recruiting
Bonn, Germany, 53127
Universitätsklinikum des Saarlandes Not yet recruiting
Homburg, Germany, 66421
Philipps Universität Marburg Not yet recruiting
Marburg, Germany, 35043
LMU - Klinikum der Universität München, Campus Großhadern Not yet recruiting
Munich, Germany, 81377
Universitätsklinikum Würzburg Not yet recruiting
Wurzburg, Germany, 97080
Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl Not yet recruiting
Meldola, Italy, 47014
European Institute of Oncology (EIO) Not yet recruiting
Milano, Italy, 20141
Netherlands
Academic Medical Center, University of Amsterdam Not yet recruiting
Amsterdam, Netherlands, 1100DD
Poland
MSC Memorial Cancer Centre Not yet recruiting
Gliwice, Poland, 44-100
Jagiellonian University Not yet recruiting
Krakow, Poland, 31-501
Medical University of Warsaw Not yet recruiting
Warsaw, Poland, 02-097
South Africa
University of Pretoria & Steve Biko Academic Hospital Not yet recruiting
Pretoria, South Africa, 0001
Switzerland
Universitätsspital Basel Not yet recruiting
Basel, Switzerland, 4031
Inselspital, Universitätsspital Bern Not yet recruiting
Bern, Switzerland, 3010
United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust Not yet recruiting
Liverpool, United Kingdom, L7 8XP
Royal Free NHS Foundation Trust Not yet recruiting
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
ITM Solucin GmbH
ABX CRO
  More Information

Responsible Party: ITM Solucin GmbH
ClinicalTrials.gov Identifier: NCT03049189     History of Changes
Other Study ID Numbers: ITM-LET-01
Study First Received: January 13, 2017
Last Updated: August 17, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ITM Solucin GmbH:
non-functional and functional P-NET
non-functional GE-NET

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pharmaceutical Solutions
Everolimus
Sirolimus
Octreotide
Edotreotide
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 19, 2017