Somatostatin Analogues for Neuroendocrine Tumors

(REMAIN Trial)

Not yet recruiting at 1 trial location
NT
Overseen ByNikolaos Trikalinos, MD, MS
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a multicenter, randomized, open-label, phase III study comparing standard of care use of somatostatin analogues (SSAs) to standard of care observation in patients with neuroendocrine neoplasms following treatment with Peptide Receptor Radionuclide Therapy (PRRT) (ethanol-stabilized Lu-177 dotatate).

Who Is on the Research Team?

NT

Nikolaos Trikalinos, MD, MS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with nonfunctional neuroendocrine tumors (carcinoid tumors) who have already received PRRT treatment. Participants should be in stable condition after PRRT and able to attend regular follow-ups.

Inclusion Criteria

I am at least 18 years old.
My doctor says I can receive somatostatin analogue treatment.
I am able to care for myself and do daily activities.
See 6 more

Exclusion Criteria

History of allergic reactions to compounds chemically or biologically similar to SSAs
Evidence of hypersensitivity to ethanol-containing compounds
Pregnant and/or breastfeeding; women of childbearing potential must have a negative pregnancy test within 15 days of study entry
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • Somatostatin Analogues

Trial Overview

The study compares two approaches after PRRT: continuing treatment with somatostatin analogues (SSAs) versus simply observing patients without further immediate medication. Patients are randomly assigned to one of these groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Somatostatin Analogue (SSA)Experimental Treatment1 Intervention
Group II: Arm 2: ObservationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Curium US LLC

Industry Sponsor

Trials
6
Recruited
1,000+