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A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET (SORENTO)

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ClinicalTrials.gov Identifier: NCT05050942
Recruitment Status : Recruiting
First Posted : September 21, 2021
Last Update Posted : August 22, 2023
Sponsor:
Information provided by (Responsible Party):
Camurus AB

Study Description
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Brief Summary:
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.

Condition or disease Intervention/treatment Phase
Gastro-enteropancreatic Neuroendocrine Tumor Drug: CAM2029 Drug: Octreotide LAR Drug: Lanreotide ATG Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET
Actual Study Start Date : October 22, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2026

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CAM2029 Drug: CAM2029
CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection
Active Comparator: Octreotide LAR or lanreotide ATG Drug: Octreotide LAR
Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection

Drug: Lanreotide ATG
Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC) [ Time Frame: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months ]
    PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 2 years following the primary efficacy analysis ]
    The time from the date of randomization to the date of death due to any cause

  2. PFS as assessed by local Investigators [ Time Frame: From date of randomization until disease progression or death due to any cause, whichever comes first, assessed up to 48 months ]
    PFS is defined as time from the date of randomization to the date of the first documented disease progression as per RECIST 1.1 or death due to any cause (whichever occurs first)

  3. Overall response rate [ Time Frame: From date of randomization until disease progression, assessed up to 48 months ]
    The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1

  4. Disease control rate [ Time Frame: From date of randomization until disease progression, assessed up to 48 months ]
    The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1

  5. Time to tumor response [ Time Frame: From date of randomization until disease progression, assessed up to 48 months ]
    The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1

  6. Duration of response [ Time Frame: From date of randomization until disease progression or death due to underlying cancer, whichever comes first, assessed up to 48 months ]
    The time from the date of the first documented response of CR or PR to the date of the first documented progression or death due to underlying cancer, as per BIRC according to RECIST 1.1

  7. Incidence of treatment-emergent adverse events [ Time Frame: From screening to the safety follow-up, assessed up to 6 years ]

Eligibility Criteria
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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:

  • Male or female patient ≥18 years old
  • Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
  • At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization)
  • ECOG performance status of 0 to 2

Exclusion Criteria:

  • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease
  • Known central nervous system metastases
  • Consecutive treatment with long-acting SSAs for more than 6 months before randomization
  • Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR
  • Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
  • Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening
  • Previously received radioligand therapy (PRRT) at any time
Contacts and Locations
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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): NCT05050942


Contacts
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Contact: Camurus AB +46 46 286 57 30 medicalinfo@camurus.com

Locations
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Sponsors and Collaborators
Camurus AB
Investigators
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Principal Investigator: Simron Singh, MD, MPH Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
More Information
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Responsible Party: Camurus AB
ClinicalTrials.gov Identifier: NCT05050942    
Other Study ID Numbers: HS-19-657
2021-000849-40 ( EudraCT Number )
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camurus AB:
CAM2029
GEP-NET
Octreotide
SORENTO
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Octreotide
Lanreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents