Trial record 1 of 1 for:
nct 05050942
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 |
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Recruitment Status :
Active, not recruiting
First Posted : September 21, 2021
Last Update Posted : January 26, 2024
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Sponsor:
Camurus AB
Information provided by (Responsible Party):
Camurus AB
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 332 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 |
Resource links provided by the National Library of Medicine
| 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 |
Primary Outcome Measures :
- 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 :
- 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
- 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)
- 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
- 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
- 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
- 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
- Incidence of treatment-emergent adverse events [ Time Frame: From screening to the safety follow-up, assessed up to 6 years ]
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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
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
Locations
Show 98 study locations
Sponsors and Collaborators
Camurus AB
Investigators
| Principal Investigator: | Simron Singh, MD, MPH | Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada |
| 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: | January 26, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Camurus AB:
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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 |