Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Gastrointestinal Agents

All Drugs and Chemicals

Octreotide

Lanreotide

Antineoplastic Agents, Hormonal

CAM2029 (octreotide subcutaneous depot) 20 mg will be administered every 2 weeks as a subcutaneous injection

CAM2029

Octreotide LAR 30 mg will be administered every 4 weeks as an intramuscular injection

Octreotide LAR

Lanreotide ATG 120 mg will be administered every 4 weeks as a deep subcutaneous injection

Lanreotide ATG

Simron Singh, MD, MPH

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.

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

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

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)

The time from the date of randomization to the date of death due to any cause

The proportion of patients with best overall response of complete response (CR) or partial response (PR), as per BIRC according to RECIST 1.1

The proportion of patients with a best overall response of CR, PR or stable disease (SD), as per BIRC according to RECIST 1.1

The time from the date of randomization to the first documented response of CR or PR, as per BIRC according to RECIST 1.1

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

Camurus AB

Digestive System Diseases

Symptoms and General Pathology

Liver Diseases

Cysts

Gastrointestinal Diseases

Pathological Conditions, Anatomical

Polycystic Liver Disease

Hematinics

Liver Extracts

0.5 mL CAM2029 10 mg, subcutaneous (SC) injection, once weekly

0.5 mL CAM2029 10 mg, SC injection, every 2 weeks and 0.5 mL placebo, SC injection, once every 2 weeks (alternating with CAM2029 dosing)

0.5 mL placebo, SC injection, once weekly

Placebo

Joost Drenth, MD

The purpose of the trial is to compare the effectiveness and safety of 2 treatment regimens of CAM2029 (given weekly or every 2 weeks) to placebo in participants with symptomatic PLD, either isolated as in autosomal dominant PLD (ADPLD) or associated with autosomal dominant polycystic kidney disease (ADPKD).

In the Treatment Period of the trial, participants will be allocated at random to 1 of the 3 treatment arms in a 1:1:1 ratio. After completing the Treatment Period (53 weeks) participants may proceed to a 24-week open-label extension part of the trial and then only receive the same CAM2029 treatment.

The active ingredient in CAM2029, octreotide, is administered as a subcutaneous depot using Camurus' FluidCrystal® technology.

A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD

A Randomized, Placebo-controlled, Double-blind, Multi-center Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Symptomatic Polycystic Liver Disease

Change from baseline to Week 53 in htTLV as determined by MRI volumetry

Key secondary endpoint. Change from baseline to Week 53 in the PLD-S measure score

Change from baseline in htTLV as determined by MRI volumetry

Change from baseline in the PLD-S measure score

Change from baseline in htTKV as determined by MRI volumetry

Change from baseline in eGFR, assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation using serum concentrations of creatinine and cystatin C

Change from baseline in the PLD-I measure score

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET	NCT05050942	Gastro-enteropa...	CAM2029 Octreotide LAR Lanreotide ATG	18 Years -	Camurus AB
A Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With PLD	NCT05281328	Polycystic Live...	CAM2029 Placebo	18 Years -	Camurus AB

Spots Global Cancer Trial Database for cam2029

Every month we try and update this database with for cam2029 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cam2029

Every month we try and update this database with for cam2029 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cam2029 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.