Clinical Trial: Treatment of IBS with diarrhoea – titrated ondansetron (TRITON)

Clinical Trial: Treatment of IBS with diarrhoea – titrated ondansetron (TRITON)

Clinical Trials
I was never diagnosed with Irritable Bowel Syndrome (IBS) but sometimes I feel like I now have it.  I know many others feel the same way.  But when I look at the alternatives, I can't help thinking it's a small price to pay given that one of them might be a slow degrading quality of life until shuffling off  this mortal coil. If I had the choice again, I would still take the surgery. Before the article continues, let me be clear - I'm not suggesting this is a potential treatment for NET patients with post abdominal surgery side effects or side effects of any other treatment, nor am I suggesting it's a potential treatment for those with carcinoid syndrome diarrhea.  I publish it because there is a connection to…
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Clinical Trial: Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (TALENT)

Clinical Trial: Lenvatinib Efficacy in Metastatic Neuroendocrine Tumors (TALENT)

Clinical Trials
"Interestingly, the ORR in pancreatic NETs was 44%, a rate not seen before with targeted agents," Jonathan Strosberg, MD, head of the neuroendocrine tumor division at Moffitt Cancer Center in Tampa Tweet Lenvatinib has completed a Phase 2 trial in Gastrointestinal (GI) and Pancreatic Neuroendocrine Tumours.  The trial was sponsored by Grupo Espanol de Tumores Neuroendocrinos (Spanish NET scientific organisation) and the manufacturers.  A European venture with sites in Austria, Italy, Spain, UK.   Headline: The responses are better than Everolimus (Afinitor) and Sunitinib (Sutent).What is Lenvatinib?It is a type of targeted therapy known as a multikinase inhibitor. The brand name is 'LENVIMA'. These work by inhibiting multiple intracellular and cell surface kinases, some of which are implicated in tumour growth and metastatic progression of cancer, thus decreasing tumour growth…
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Clinical Trial: Intra-arterial Lu177 (PRRT) for Neuroendocrine Cancer liver metastases (LUTIA)

Clinical Trial: Intra-arterial Lu177 (PRRT) for Neuroendocrine Cancer liver metastases (LUTIA)

Clinical Trials
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email The treatment of liver metastasis is a common approach following a metastatic diagnosis or discovery of liver metastasis downstream via re-staging. In addition to surgery, there are several liver directed therapies available via embolization techniques. This comes in several flavours:1. Bland liver embolization - a minimally invasive technique which simply blocks the blood supply to the liver tumours in an attempt to reduce or kill those tumours. Sometimes called Hepatic Arterial Embolization or HAE.2. Chemotherapy liver embolization - as above but adds in some cytotoxic chemo to the mix. Sometimes called Trans Arterial Chemo Embolization or TACE.3. Radioembolization is a minimally invasive procedure that combines embolization and radiation therapy to…
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Clinical Trial SPARTALIZUMAB  – Immunotherapy for Neuroendocrine Neoplasms (PDR001)

Clinical Trial SPARTALIZUMAB – Immunotherapy for Neuroendocrine Neoplasms (PDR001)

Clinical Trials, Treatment
PDR001 (anti-PD-1) is an investigational immunotherapy being developed by Novartis to treat both solid tumors and lymphomas (cancers of the blood).  It is currently being trialled on many cancers including Neuroendocrine.  Its brand name is SPARTLIZUMAB. How PDR001 works PDR001 is a type of immunotherapy, meaning that it acts by activating the body’s own immune system to recognize and fight cancer cells. Normally, an immune system cell called T-cells recognizes and kills infected or abnormal cells, including those that are cancerous. To prevent T-cells from accidentally damaging healthy and essential tissues, however several immune system checkpoints exist to inhibit, or block, them from going about this work. One example is the programmed cell death 1 (PD-1) pathway. Healthy cells produce and display a protein called programmed cell death ligand-1 or…
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Breath test with the goal of detecting multiple cancers – ready to start trials

Breath test with the goal of detecting multiple cancers – ready to start trials

Clinical Trials
While it's a long way off becoming reality, this is quite an exciting clinical trial. I have no idea if it will pick up Neuroendocrine disease but initially, patients with suspected oesophageal and stomach cancers will be asked to try the test. Later it will be extended to include prostate, kidney, bladder, liver and pancreatic cancers. It's possible that Neuroendcorine tumours in these locations might be picked up or at least show up some abnormality that triggers further checks. The fact that Cancer Research UK is involved gives me some confidence as they tend to back the strong horses. I will keep this article live and track developments. Read more by clicking here. Thanks for reading Ronny I’m also active on Facebook. Like my page for even more news. I’m also…
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Q-Sphera™ – Next Generation Somatostatin Analogue delivery system?

Q-Sphera™ – Next Generation Somatostatin Analogue delivery system?

Clinical Trials, Living with Neuroendocrine Cancer, Treatment
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email UPDATE: In March 2020, the decision was taken to terminate further in-house development of the MTD201 programme with immediate effect although the asset remains available for licensing. All activities connected with MTD201 have been wound down expeditiously and the manufacturing facilities in Bilbao have been closed. Following the termination of in-house development of MTD201, the Company realigned its strategy towards exploiting its Q-Sphera technology more broadly.Original Article belowIn my article listing the somatostatin analogues and their drug delivery systems pipeline (click here), there has been a very interesting development in a product called Q-Sphera (was previously known as Q-Octreotide).  In a press release, it was announced that an unnamed 'pharma giant'…
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Neuroendocrine Cancer Clinical Trial – Lutetium-177 OPS-201 (Satoreotide)

Neuroendocrine Cancer Clinical Trial – Lutetium-177 OPS-201 (Satoreotide)

Clinical Trials
This trial drug was once owned by Ipsen but they decided to sell it off.  However, in Jun 2022, Ariceum Therapeutics (Ariceum), a private biotech company developing a radiopharmaceutical product for the diagnosis and systemic targeted radiation therapy of certain hard-to-treat cancers, announced the successful investment source of EURO 25 Million.  The proceeds from the financing will enable Ariceum to further develop its lead asset and proprietary peptide derivative, satoreotide. Satoreotide is a radiopharmaceutical drug and an antagonist of the somatostatin type 2 (SST2) receptor which is overexpressed in many cancers, including certain hard-to-treat cancers such as small cell lung cancer (SCLC), high-grade neuroendocrine tumours (NETs) and neuroblastoma, an aggressive, rare type of cancer that occurs mainly in young children. Satoreotide will be used as a 'theranostic' for both the diagnosis and…
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Neuroendocrine Cancer – Short Update from NANETS 2018

Neuroendocrine Cancer – Short Update from NANETS 2018

Clinical Trials, Diet and Nutrition, Living with Neuroendocrine Cancer, Patient Advocacy, Survivorship
I would love to go to a NANETS conference but I would need sponsorship or otherwise have to fund my own way there. Seattle sounds like a great place to visit. I would even have been their twitter correspondent had they asked! I've been to the European equivalent twice, they always have theirs in Barcelona it would seem, at least NANETS uses different locations making it more interesting.  It's a scientific conference for the most part, but I guess some basic stuff is also covered. However, in the world of instant contact and communications on the internet, together with twitter, one can keep up to speed on what is or has been discussed.  One day, NANETS and ENETS will be sufficiently advanced that we can all watch the presentations from…
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Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

Detectnet™ (64Cu-DOTATATE) – an expansion of the Somatostatin Receptor PET Imaging for Neuroendocrine Cancer

Clinical Trials, Living with Neuroendocrine Cancer, Treatment
Edit 21st January 2021.  The imaging time window of 64Cu-DOTATATE positron emission tomography/computed tomography (PET/CT) for patients with neuroendocrine neoplasms can be expanded from one hour to three hours post-injection, according to new research published in the January 2021 issue of The Journal of Nuclear Medicine.  Read more here Edit 4th September 2020.  64Cu-dotatate now named Detectnet™ is approved for use by US FDA. Majority read revealed Detectnet had over 98% accuracy, 100% sensitivity, and over 96% specificity to confirm or exclude presence of disease. Read more here.  Edit 14th July 2020.  Expanded Access Program via clinical trial now recruiting - see below.  The objective of this trial is to provide patients with confirmed or suspicion of NET access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of…
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177Lu-DOTA-EB-TATE – Long-lasting radionuclide therapy for advanced neuroendocrine tumors proves effective

177Lu-DOTA-EB-TATE – Long-lasting radionuclide therapy for advanced neuroendocrine tumors proves effective

Clinical Trials
In the NewsUpdate in March 2021.  Molecular Targeting Technologies, Inc. (MTTI), a clinical stage radiopharmaceutical therapy company, announced the approval of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). It enables a Phase I clinical study of the Safety and Dosimetry of its lead product, EBTATE (177Lu-DOTA-EB-TATE), in patients with neuroendocrine tumors (NET).  Clinical Trial number to follow. EBTATE is used in Precision Medicine for Targeted Radionuclide Therapy. The key feature of this technology is the appendage of Evans blue (EB) to the targeting radiopharmaceutical. EB binds reversibly to serum albumin to enhance the radiotherapeutic time window with longer circulation half-life and increase tumor uptake/retention to improve therapeutic outcome.Dr. Chris Pak, President & CEO of MTTI commented: “The clearance of our IND is an important…
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Sapanisertib – a drug on trial for Neuroendocrine Tumors (NET) with a pancreatic primary

Sapanisertib – a drug on trial for Neuroendocrine Tumors (NET) with a pancreatic primary

Clinical Trials, Treatment
Researchers are testing the drug Sapanisertib to see if it can halt the progression of pancreatic NETs (pNETs) which cannot be surgically removed, have not responded to other treatment, and have spread to other parts of the body. What is Sapanisertib? Sapanisertib is one of a group of targeted therapy drugs that interferes with tumor progression by inhibiting an enzyme known as mTOR which a tumor cell needs for growth.  In fact this is the same technique used in Afinitor (Everolimus), already approved for NETs. It is also being tested in a number of different advanced cancers, including bladder, kidney, breast, liver, and certain types of lung cancers, among others. The Clinical Trial The primary goal of the phase II study is to evaluate how well pNET tumors respond to Sapanisertib.…
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Update – Oncolytic Virus Trials for Neuroendocrine Cancer

Update – Oncolytic Virus Trials for Neuroendocrine Cancer

Clinical Trials
What exactly are Oncolytic Viruses?Oncolytic Viruses infect and break down cancer cells but not normal cells. Oncolytic viruses can occur naturally or can be made in the laboratory by changing other viruses. Certain oncolytic viruses are being studied in the treatment of cancer. Some scientists say they are another type of immunotherapy whilst others say it's too early to classify them as such. The good news is that Neuroendocrine Cancer seems to figure in this work with two of these viruses apparently working on mice to date. Listed below are two active projects involving NETs, one directly and one indirectly.Added 4th August 2022. Ph I/II Trial of Systemic VSV-IFNβ-NIS and Pembrolizumab in NECA small trial based in Mayo Minnesota. The trial target population includes pembrolizumab refractory Neuroendocrine Carcinoma (NEC) in…
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Targeted Alpha-emitter Therapy (TAT) – the wave of the future in nuclear oncology/PRRT?

Targeted Alpha-emitter Therapy (TAT) – the wave of the future in nuclear oncology/PRRT?

Clinical Trials
What is Targeted Alpha-emitter Therapy?Regular PRRT which is authorised for use now, i.e. Lutathera/Lu177 is a beta therapy.  Targeted Alpha Therapy is based on the coupling of alpha particle emitting radioisotopes to tumour selective carrier molecules, such as monoclonal antibodies or peptides. These molecules have the ability to selectively target tumour cells even if they are spread throughout the body. They recognize the targeted cancer cells through antigens that are expressed on the cell surface and can bind selectively to these cells, similar a key fitting into a lock. In targeted alpha therapy these carrier molecules serve as vehicles to transport the radioisotopes to the cancer cells. This is called the "magic bullet" approach. Radioisotopes that emit alpha particles seem particularly promising to selectively destroy cancer cells. Alpha particles have…
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Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

Phase 3 Clinical Trial of 177Lu-Edotreotide (Solucin®) – COMPETE for GEPNETs

Clinical Trials
Graphic courtesy of ITM In the News. On the heels of the approval of PRRT in USA and UK and elsewhere, here's news of a new PRRT compound undergoing a phase 3 clinical trial.  ITM Isotope Technologies Munich SE, a specialized radiopharmaceutical company, today (7th Dec 2017) announced the enrolment of the first patient recruited in Europe for the COMPETE phase III clinical trial at the University Hospital Marburg, Germany. The CEO of ITM said "This marks the starting point of COMPETE in Europe, whereby we expect a rapid increase in the number of recruits.”What is the COMPETE TRIAL? COMPETE is led as an international pivotal multi-center phase III clinical trial evaluating the efficacy and safety of (no-carrier-added) n.c.a.177Lu-Edotreotide (Solucin®) and the trial is comparing it to Everolimus (Afinitor). The trial runs…
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Lanreotide for Lung NETs – SPINET Clinical Trial

Lanreotide for Lung NETs – SPINET Clinical Trial

Clinical Trials, Treatment
Reviewed and updated 19th October 2021.  Phase III trial data updatedThere's been a lot of action in the area of what is termed Gastro-Entero-Pancreatic Neuroendocrine Tumors (GEP-NETs).  It can therefore sometimes appear that Lung NETs are the poor relation.  There are certainly some unmet needs in this area of the anatomy including a lack of research.  However, there has been some recent movement. Last year, the use of Afinitor (Everolimus) was approved for progressive, non-functional NET of GI or Lung origin.SPINET Trial for Lung NETsIn late 2016, I tipped you off about an Ipsen sponsored trial for Lung NETs involving Lanreotide (Somatuline).  SPINET is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of Lanreotide plus "Best Supportive Care" (BSC) versus placebo plus BSC for the treatment…
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Immunotherapy: Studies with Neuroendocrine Neoplasms

Immunotherapy: Studies with Neuroendocrine Neoplasms

Clinical Trials, Treatment
IntroductionThere's a lot of Immunotherapy stuff out there! However, I also wanted to break it down and perhaps see if I can pick up the what, when, why, where and how in regard to Neuroendocrine Cancer. It's difficult, not least because the picture is not clear and there is no general roadmap printed, let alone one for Neuroendocrine disease. Immunotherapy for NETs was discussed at ENETS 2017 in Barcelona. The presentation that sticks out was one given by Dr Matthew Kulke, a well-known NET Specialist in Boston. My reaction to the presentation was one of 'expectation management' and caution i.e. it's too soon to know if we will get any success and when we will get it. He also hinted that it's more likely that any success will first be…
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ASCO 2017 – Let’s talk about NETs #ASCO17

ASCO 2017 – Let’s talk about NETs #ASCO17

Clinical Trials
ASCO (American Society of Clinical Oncology) is one of the biggest cancer conferences in the world normally bringing together more than 30,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field.  As Neuroendorine Tumors is on a roll in terms of new treatments and continued research, we appear to be well represented with over 20 'extracts' submitted for review and display.  This is fairly complex stuff but much of it will be familiar to many.  I've filtered and extracted all the Neuroendocrine stuff into one list providing you with an easy to peruse table of contents, complete with relevant linkages if you need to read more.  For many the extract title and conclusion will be sufficiently educational or at least…
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All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

All you need to know about Peptide Receptor Radionuclide Therapy (PRRT)

Clinical Trials, Treatment
Update June 6th 2021. Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera. New analysis of the NETTER-1 trial data has been published. For those who just need a quick summary, the quote from Dr Jonothan Strosberg is below. Short PRRT PrimerWhat is Peptide Receptor Radionuclide Therapy (PRRT)?For those who are still not sure what it's all about. This is a non-surgical treatment which is normally administered intravenously. It's based on the use of somatostatin receptors to attract a 'radiopeptide'. The radiopeptide is a combination of a somatostatin analogue and a radioactive material. As we already know, somatostatin analogues (i.e. Lanreotide/Octreotide) are a NET cell targeting drug using somatostatin receptors, so when combined with radioactivity, it binds with…
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Clinical Trial – Cabozantinib for Neuroendocrine Neoplasms

Clinical Trial – Cabozantinib for Neuroendocrine Neoplasms

Clinical Trials
What is Cabozantinib?Cabozantinib is an oral drug which works by blocking the growth of new blood vessels that feed a tumour. In addition to blocking the formation of new blood cells in tumours, Cabozantinib also blocks pathways that may be responsible for allowing cancers cells to become resistant to other "anti-angiogenic" drugs. It is a type of drug called a growth blocker.  Cabozantinib has been studied or is already in research studies as a possible treatment for various types of cancer, including prostate cancer, ovarian cancer, brain cancer, thyroid cancer, lung cancer, and kidney cancer. During my research, I found that it has a connection to Medullary Thyroid Cancer (MTC) which is a type of Neuroendocrine Cancer, frequently associated with Multiple Endocrine Neoplasia (MEN).  Cabozantinib, under the brand name of 'Cometriq'…
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Theranostics for Neuroendocrine Cancer –  A Find and Destroy Mission

Theranostics for Neuroendocrine Cancer – A Find and Destroy Mission

Awareness, Clinical Trials, Living with Neuroendocrine Cancer, Treatment
[caption id="attachment_14426" width="1200"] Courtesy of Pashtoon Kasi MD on Twitter https://twitter.com/pashtoonkasi/status/1078675398601396224[/caption] Theranostics is a joining of the words therapeutics and diagnostics. You may also see it conveyed as 'Theragnostics' and these terms are interchangeable. The basic aim of theranotistics is to find and then destroy the 'bad guys'. With Neuroendocrine Cancer, finding the tumours (the bad guys) can often be a challenge - they can be small and/or difficult to find - they are sometimes expert at camouflage. Moreover, once found, they can then be difficult to treat (destroy), as they can often prove resistant to conventional cancer drugs and many are inoperable due to sheer quantity, spread and positioning. When they are found and identified, it's also really helpful to know from the intelligence gathered, how successful the destroy…
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Clinical Trial: PRRT and Chemo combination therapy

Clinical Trial: PRRT and Chemo combination therapy

Clinical Trials
Update 2022:  Trial complete.  Results:The final results of this trial were presented at ASCO 2022 where it was concluded as follows:"CONTROL NETs is the first randomized trial to demonstrate efficacy for PRRT in pNETs, in addition to a standard of care. Extended follow up confirms durable CAPTEM/PRRT activity, with superior PFS in pNETs. Late haematologic toxicity was seen in both mNET PRRT arms but was not higher with additional CAPTEM. The activity of CAPTEM/PRRT in pNETs should be tested in the phase III setting" - click here to read the abstract. Combination treatments are common in chemotherapy, but this trial was different as it effectively combined the use of different therapies both with their own toxicity risks, albeit low in each therapy type.  The use of PRRT and chemo (in particular…
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Somatostatin Analogues and delivery methods in the pipeline

Somatostatin Analogues and delivery methods in the pipeline

Awareness, Clinical Trials, Living with Neuroendocrine Cancer
This is my live blog post covering new developments in the area of new Somatostatin Analogues and new delivery systems.  Abstract As most of you will be aware, there are currently two main types of Somatostatin Analogues (SSA) in use for the treatment of mainstream Neuroendocrine Tumours (NETs) - Octreotide and Lanreotide.  You can click on the links for information on both of these well-known NET treatments.  This post will focus on the not so well known and anything in the pipeline including different delivery systems. Those who have read the Octreotide/ Lanreotide patient leaflets will know those SSAs are also used in the treatment of a condition known as Acromegaly. You can see why the drug is used for both as they control the release of excess secretions of…
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