PRRT for Neuroendocrine Tumors
(COMPETE Trial)

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ITM Solucin GmbH

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET).

Research Team

Eligibility Criteria

This trial is for adults with certain types of neuroendocrine tumors in the digestive system or pancreas that can't be removed by surgery. Participants must have a confirmed diagnosis, measurable disease, positive somatostatin receptor status, and evidence of disease progression. They cannot have had certain prior treatments like mTor inhibitors or PRRT, nor can they be pregnant or unable to consent.

Inclusion Criteria

My cancer has grown despite treatment, confirmed by two scans.

My condition is positive for somatostatin receptors.

Measurable disease per RECIST 1.1

See 1 more

Exclusion Criteria

I have kidney, liver, heart, or blood issues that could affect my safety during the study.

I am allergic to certain cancer treatment drugs or their ingredients.

My doctor believes surgery could potentially cure my condition.

See 9 more

Treatment Details

Interventions

177Lu-edotreotide PRRT (Peptide Receptor Radionuclide Therapy)
Everolimus (Targeted Molecular Therapy)

Trial OverviewThe study compares two treatments: Peptide Receptor Radionuclide Therapy (PRRT) using a radioactive drug called 177Lu-Edotreotide versus Everolimus, a targeted molecular therapy. The goal is to see which treatment is more effective and safer for patients with advanced neuroendocrine tumors.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: 177Lu-edotreotide PRRTExperimental Treatment2 Interventions

177Lu-edotreotide (177Lu-DOTATOC) A maximum of four cycles of 7.5 ± 0.7 GBq (gigabequerel) 177Lu-edotreotide, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 4 cycles, 90 days apart (total duration: 270 days/9 months)

Group II: EverolimusActive Control1 Intervention

Everolimus (Afinitor ®) Doses: 10 mg/d Route of administration: Oral Duration of treatment: Continuous daily treatment until diagnosis of progression or End of Study (EOS)