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Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)

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ClinicalTrials.gov Identifier: NCT04919226
Recruitment Status : Not yet recruiting
First Posted : June 9, 2021
Last Update Posted : June 9, 2021
Sponsor:
Information provided by (Responsible Party):
ITM Solucin GmbH

Brief Summary:
The purpose of the study is to evaluate the efficacy, safety & patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT Drug: CAPTEM (Capecitabine and Temozolomide) Other: Amino-Acid Solution Drug: Everolimus 10 mg Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2026


Arm Intervention/treatment
Experimental: Peptide Receptor Radionuclide Therapy (PRRT) Arm Drug: 177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT
Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
Other Name: 177Lu-DOTATOC 177Lu-Edo

Other: Amino-Acid Solution
The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
Other Name: Arginine-Lysine Solution

Active Comparator: CAPTEM(Capecitabine-Temozolomide), Everolimus, FOLFOX(Folinic acid + Fluorouracil + Oxaliplatin) Drug: CAPTEM (Capecitabine and Temozolomide)
Best standard of care treatment (investigator's choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

Drug: Everolimus 10 mg
Best standard of care treatment (investigator's choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.

Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Best standard of care treatment (investigator's choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.




Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: Every 12 weeks from randomization until disease progression or death whichever occurs earlier, during the time necessary to observe 148 Progression Free Survival (PFS) events. ]
    PFS (Progression-Free Survival), defined as the time from randomization until documented RECIST v1.1 (Response evaluation criteria in solid tumors) progression.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 2 years after disease progression ]
    OS (Overall Survival), defined as the time from randomization until death;



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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:

  • Patients aged ≥ 18 years.
  • Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
  • Somatostatin receptor-positive (SSTR+) disease.

Exclusion Criteria:

  • Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g. rapamycin).
  • Prior (Peptide Receptor Radionuclide Therapy) PRRT.
  • Any major surgery within 4 weeks prior to randomization in the trial.
  • Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
  • Other known malignancies.
  • Serious non-malignant disease.
  • Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
  • Pregnant or breastfeeding women.
  • Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that.

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): NCT04919226


Contacts
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Contact: Nicolas Schneider, Dr info@itm-solucin.de
Contact: Martina Herrmann, MD info@itm-solucin.de

Sponsors and Collaborators
ITM Solucin GmbH
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Responsible Party: ITM Solucin GmbH
ClinicalTrials.gov Identifier: NCT04919226    
Other Study ID Numbers: DP-1111-02CT
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: June 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ITM Solucin GmbH:
GastroEnteroPancreatic
non-functional and functional GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NET)
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Leucovorin
Folic Acid
Fluorouracil
Capecitabine
Oxaliplatin
Everolimus
Temozolomide
Pharmaceutical Solutions
Levoleucovorin
Edotreotide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients