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Somatostatin Analog

Octreotide Depot for Neuroendocrine Tumors (SORENTO Trial)

Phase 3
Waitlist Available
Led By Simron Singh, MD, MPH
Research Sponsored by Camurus AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0 to 2
Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening to the safety follow-up, assessed up to 6 years
Awards & highlights

SORENTO Trial Summary

This trial will compare the effectiveness and safety of a new drug (CAM2029) to existing treatments (octreotide LAR or lanreotide ATG) in patients with advanced, well-differentiated GEP-NET. If the new drug is not effective, patients may receive intensified treatment in the open-label extension part of the study.

Who is the study for?
This trial is for adults with advanced, well-differentiated neuroendocrine tumors of the gut or pancreas. Participants must have at least one measurable lesion and be in fairly good health (ECOG status 0-2). They shouldn't have brain metastases, extensive prior treatments like long-term SSAs, chemoembolization within a year, radioligand therapy ever, or unmanageable carcinoid symptoms.Check my eligibility
What is being tested?
The study tests CAM2029 against two established drugs: octreotide LAR and lanreotide ATG. It aims to see which is more effective and safer for patients with GEP-NET. If disease progresses during the study, participants may receive an intensified treatment of CAM2029 in an open-label extension part.See study design
What are the potential side effects?
Potential side effects include digestive issues such as diarrhea or stomach pain; blood sugar changes; gallstones; injection site reactions; fatigue; and possibly allergic reactions. The exact side effects will vary between the medications being tested.

SORENTO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My cancer is a type that started in the digestive system and cannot be surgically removed.

SORENTO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening to the safety follow-up, assessed up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to the safety follow-up, assessed up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) as assessed by a Blinded Independent Review Committee (BIRC)
Secondary outcome measures
Disease control rate
Duration of response
Incidence of treatment-emergent adverse events
+4 more

SORENTO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CAM2029Experimental Treatment1 Intervention
Group II: Octreotide LAR or lanreotide ATGActive Control2 Interventions

Find a Location

Who is running the clinical trial?

Camurus ABLead Sponsor
8 Previous Clinical Trials
1,530 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
12 Patients Enrolled for Neuroendocrine Tumors
Simron Singh, MD, MPHPrincipal InvestigatorOdette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Media Library

CAM2029 (Somatostatin Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05050942 — Phase 3
Neuroendocrine Tumors Research Study Groups: CAM2029, Octreotide LAR or lanreotide ATG
Neuroendocrine Tumors Clinical Trial 2023: CAM2029 Highlights & Side Effects. Trial Name: NCT05050942 — Phase 3
CAM2029 (Somatostatin Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05050942 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many applicants will be able to join this research project?

"The sponsor, Camurus AB, needs to recruit 300 individuals who match the clinical trial's inclusion criteria from various sites including East Jefferson General Hospital in Metairie, Louisiana and Mayo Clinic Rochester in Rochester, Minnesota."

Answered by AI

What other medical studies have included CAM2029 as a variable?

"First studied in 1997 at Vanderbilt University's Autonomic Dysfunction Center, CAM2029 has had a total of 137 completed studies as of today. However, there are still 21 ongoing studies recruiting patients. The majority of these trials are taking place in Metairie, Louisiana."

Answered by AI

Can you summarize the risks associated with CAM2029?

"CAM2029 rates a 3 on our Power scale due to being in Phase 3 trials--meaning that, while there is data supporting efficacy, there are multiple rounds of data affirming safety."

Answered by AI

Are there any vacancies left for this research project?

"Yes, this trial is still looking for participants. It was originally posted on October 22nd, 2021 and the most recent update was on October 21st, 2022."

Answered by AI

What are the conditions that doctors usually prescribe CAM2029 for?

"While most often used to treat neoplasm metastasis, CAM2029 can also be effective in palliating symptoms associated with octreotide, vasoactive intestinal peptide tumors, and advance directives."

Answered by AI

Who else is applying?

What site did they apply to?
Dana-Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
~72 spots leftby Dec 2024