A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With GEP-NET (SORENTO)

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Some of the key differences between Lanreotide and Octreotide long-acting are:

1.  Octreotide long-acting needs constituting prior to administration – Lanreotide comes prefilled. 

2. Octreotide long-acting is administered intra-muscular, Lanreotide is deep subcutaneous. 

3.  I probably should add Octreotide LAR cannot be self-injected but Lanreotide can.  I suspect this type of delivery system may open up that possibility for Octreotide LAR. 

So, this clinical trial caught my eye.  A version of octreotide long-acting which is prefilled and given subcutaneously.  Plus, the manufacturers say it has a much higher bioavailability than the standard product Sandostatin LAR (bioavailability is the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect).

CAM2029 might therefore be considered a generic of Sandostatin LAR but better both in the delivery system and bioavailability. 

What is CAM2029?

CAM2029 is developed for the treatment of acromegaly and neuroendocrine tumors. The product candidate offers important potential advantages over currently marketed products, including easy administration, significantly increased bioavailability, and potential for enhanced treatment efficacy in patients for whom current treatments provide suboptimal treatment effects.

CAM2029 is a ready-to-use, long-acting subcutaneous injection depot based on the active substance octreotide formulated with Camurus’ proprietary FluidCrystal® injection depot technology. It is provided as a prefilled syringe, thus not requiring any reconstitution or conditioning prior to administration. Due to the superior ease of handling and administration, CAM2029 can be conveniently administered by the patients themselves.

CAM2029 – Key target attributes
• Subcutaneous long-acting octreotide
• Fast onset and one month duration of therapeutic plasma-levels
• Provided ready-for-use in prefilled syringes for easy self-administration
• Compatible with autoinjectors
• High bioavailability – 500% higher than Sandostatin® LAR®, with potential for better treatment effects in some patients

CAM2029 – Key publications
1. Octreotide SC depot in patients with acromegaly and functioning neuroendocrine tumors: a phase 2, multicenter study
Pavel M, Borson‑Chazot F, Cailleux A, Hörsch D, Lahner H, Pivonello R, Tauchmanova L, Darstein C, Olsson H, Tiberg F, Ferone D., Cancer Chemotherapy and Pharmacology (2019) 83:375–385

2. Camurus announces dosing initiated in Phase 3 study of CAM2029 in patients with Neuroendocrine Tumors. 

The Sorento Clinical Trial

Purpose: The purpose of this study is to compare the effectiveness and safety of CAM2029 to both Octreotide LAR (Sandostatin LAR) or Lanreotide Autogel 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.

Who can take part?  Make sure you read all of the inclusion and exclusion details in the clinical trial.  I picked out a key one for each.  Included – Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin. Excluded – Previously received radioligand therapy (PRRT) at any time.

Where are the trials taking place? United States (Texas), Italy, Spain (4 hospitals). The principal investigator is well-known Canadian NET specialist Simron Singh MD.  They are looking for 300 participants across all sites. Recruiting now according to the clinical trials document. 

The full clinical trial document can be found here

Great video of FluidCrystal® injection depot from the manufacturer but it’s not clear whether any authorised drug delivery system would look like this, it could be a prototype and/or just for clinical trial use. 

General Clinical Trials Disclaimer

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided in the clinical trials document. It’s very important to check the trial inclusion and exclusion criteria before making any contact.  If you need questions, the articles here is very useful Questions to Ask About Clinical Trials | Cancer.Net

The inclusion of any trial within this blog should not be taken as a recommendation by Ronny Allan. 

 
 

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