ClinTrial Refer

Trial Acronym
HS-19-657

Registration Number
NCT05050942

Scientific 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

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.

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

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

Trial Location Name

Address

Status

Fiona Stanley Hospital (Oncology)

11 Robin Warren Dr, Murdoch WA 6150, Australia

Closed

Primary Contact : Caroline Stone, caroline.stone@health.wa.gov.au , (08) 6152 6530

Secondary Contact : Edwin Tan, Edwin.tan@health.wa.gov.au , 61861526720

Camurus AB

Website URL

Link Name

Link URL

Clinicaltrials.gov

https://clinicaltrials.gov/ct2/show/NCT05050942

ANZCTR

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=NCT05050942

Secondary IDs
2021-000849-40

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 3

Minimum Age
18

Maximum Age
100

Date Registered
18/07/2023

Date Closed
N/A

Status
Closed

Enrolment Type
By Self-Referral,By Specialist and/or Surgeon Referral,Primary Care or GP Referral

Mutation Status and Biomarker
Any or not stated

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

Back to List/Filter

to List/Filter