A prospective, single-arm, open-label study to evaluate the efficacy and safety of Surufatinib in combination with Octreotide LAR as first line treatment in G1-G2 Gastroenteropancreatic Neuroendocrine Tumors patients

Start Date01 Aug 2021

Sponsor / Collaborator

Jiangsu Cancer Hospital

NCT03541447

/ CompletedPhase 2IIT

A Pilot, Phase II Study With a Prospective, Randomized, Cross-Over, Placebo-Controlled, Double-Blind Design to Assess the Short-Term Effects of Tolvaptan Plus Placebo vs Tolvaptan Plus Octreotide LAR Combination Therapy in ADPKD Patients With Normal Kidney Function or Hyperfiltration

Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a leading cause of End Stage Kidney Disease (ESKD) worldwide. Elevated levels of 3', 5' - cyclic AMP (cAMP) play a central role in the pathogenesis and progression of the disease. Vasopressin antagonists and somatostatin analogues, which indirectly reduce adenyl cyclase 6 activity, have been found to markedly reduce renal tubular cell proliferation and cyst growth in experimental models of ADPKD. In combination, the two treatments show a clear additive effect and may significantly reduce renal cystic and fibrotic volume as well as cAMP levels to wild type levels.
The vasopressin antagonist Tolvaptan and the somatostatin analogue Octreotide share a similar renoprotective effect also in human disease.
Both medications effectively slow total kidney and cystic volume (TKV and TCV, respectively) growth and glomerular filtration rate (GFR) decline in patients with ADPKD. The short-term effect of both medications appear to be larger when the GFR is normal or even higher than normal and kidney volumes are still relatively stable. On the basis of experimental data, it is conceivable that Tolvaptan and Octreotide LAR should have an additive effect also in human disease, during initial treatment as well as in the long-term. To address the working hypothesis of an additional short-term effect of Tolvaptan and Octreotide, we propose to run a pilot, explorative, randomized, placebo-controlled, clinical trial with a Cross-Over Design to compare the short-term effects of Tolvaptan monotherapy and Tolvaptan plus Octreotide LAR combination therapy on TKV as assessed by MRI, and on GFR as directly measured by the iohexol plasma clearance technique in ADPKD patients with normal (80 to 120 ml/min/1.73m2) kidney function or even kidney hyperfiltration (GFR ≥120 ml/min/1.73m2).

Start Date12 Dec 2018

Sponsor / Collaborator

Otsuka Pharmaceutical Italy S.r.l.

NCT03057509

/ WithdrawnPhase 1IIT

A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors

This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron emission tomography (PET) scanning as a way of assessing carcinoid tumors.

Start Date01 Nov 2018

Sponsor / Collaborator

The General Hospital Corp.

100 Clinical Results associated with Octreotide depot (GP Pharm SA)

100 Translational Medicine associated with Octreotide depot (GP Pharm SA)

100 Patents (Medical) associated with Octreotide depot (GP Pharm SA)

430

Literatures (Medical) associated with Octreotide depot (GP Pharm SA)

01 Dec 2024·JOURNAL OF NEUROENDOCRINOLOGY

Real‐world effectiveness of adjuvant octreotide therapy in patients with pancreatic neuroendocrine tumors at high recurrence risk: A multicenter retrospective cohort study

Article

Author: Xu, Xuefeng ; Lou, Wenhui ; Wu, Heshui ; Jin, Gang ; Gao, Suizhi ; Bian, Yun ; Jiang, Hui ; Zhang, Yijie ; Guo, Shiwei ; Wang, Min ; Qu, Linlin ; Li, Bo ; Huang, Qiang ; Li, Gang ; Zhu, Chenglin ; Qin, Renyi ; Hu, Weiyu

Abstract:

Adjuvant therapy for pancreatic neuroendocrine tumors (PanNETs) after radical resection lacks evidence‐based data and remains controversial. This study aimed to validate whether long‐acting octreotide is a potential candidate for adjuvant therapy in patients with G2 PanNETs at high recurrence risk by clustering real‐world data. A retrospective review of patients with nonmetastatic grade 2 PanNETs who underwent radical resection at six research centers between 2008 and 2020 was conducted. Propensity score matching and inverse probability of treatment weight analysis were used to control confounding factors. Overall, 357 patients (octreotide group, n = 82; control group, n = 275) were analyzed. Kaplan–Meier survival analyses showed that the octreotide group had longer disease‐free survival (DFS) compared with the control group (36 months: 93.3% vs. 79.0%, p = .0124; 60 months: 71% vs. 67.6%, p = .0596, respectively), as well as overall survival (OS) (60 months: 98% vs. 83.8%, p = .0117, respectively). Multivariate analyses indicated that octreotide long‐acting repeatable (LAR) adjuvant therapy was associated with higher OS (p = .0270) at 60 months. Propensity score matching analysis showed that octreotide adjuvant therapy was associated with higher DFS (p = .0455) and OS (p = .0190) at 60 months. Similar results were obtained via inverse probability of treatment weight analysis. Subgroup analysis indicated that octreotide LAR was associated with a high DFS in patients with lymph node metastasis or Ki‐67 <10% PanNETs. Adjuvant therapy with long‐acting octreotide following radical resection of nonmetastatic G2 PanNETs may be associated with improved DFS and OS in a real‐world setting.

01 Oct 2024·HPB

Prophylactic somatostatin analogs for postoperative pancreatic fistulas: a cross-sectional survey of AHPBA surgeons

Article

Author: Chauhan, Sardar Shahmir B ; Sham, Jonathan G ; Park, James O ; Pillarisetty, Venu G ; Vierra, Benjamin ; Davidson, Giana H

BACKGROUND:

Postoperative pancreatic fistulas lead to substantially increased morbidity, mortality, and healthcare costs after pancreatectomy. Studies have reported conflicting data on the role of prophylactic somatostatin analogs in the reduction of postoperative pancreatic fistula. Current practice patterns, surgeon beliefs, and barriers to using these drugs in the Americas is not known.

METHODS:

An online 26-question cross-sectional survey was distributed via email to the members of the Americas Hepato-Pancreato-Biliary Association in April 2023.

RESULTS:

One hundred and two surgeons responded in spring 2023. 48.0% of respondents reported using prophylactic SSAs during their surgical training, however, only 29.4% do so in their current practice, most commonly when performing Whipple procedures. Octreotide was the most frequently used SSA (34.3%), followed by octreotide LAR (12.7%) and pasireotide (11.8%). Reasons for not prescribing included a lack of high-quality data (62.7%), perception of limited efficacy (34.3%) and high cost (30.4%).

CONCLUSION:

These results highlight key areas for future study including understanding surgeon rationale for patient and drug selection. Variable practice patterns amongst surgeons also underscore the importance of generalizability in the design of future clinical trials in order to maximize impact.

01 Oct 2024·GROWTH HORMONE & IGF RESEARCH

Medical treatment of acromegaly – When the tumor size matters: A narrative review

Review

Author: Milicevic, Mihajlo ; Stojanovic, Marko ; Miljic, Dragana ; Doknic, Mirjana

Medical treatment of acromegaly is generally positioned as a second line of treatment after pituitary adenoma surgery. With the rising availability and variety of medications for acromegaly increases our understanding of their effectiveness and safety. Volume of the published data on the impact of medical therapy on biochemical control of acromegaly, contrasts a relative lack of publications which comprehensively address pituitary tumor alterations under different drug modalities. Assessment of changes in GH-secreting adenoma volume is often overshadowed by clinicians' focus on GH and IGF-I levels during acromegaly treatment. Close analysis of studies published in the last two decades, reveals that both an increase and decrease in somatotropinoma volume are possible during treatment with any of available drugs for acromegaly. Changes in pituitary tumor size may arise from the biological nature of adenoma itself, independently of the administered medications. Therefore, an individual approach is necessary in the treatment of patients with acromegaly, based on repeated insight to their clinical, biochemical, pathological and imaging characteristics. In this review, we summarize and comment how pituitary tumor size is affected by the treatment with all currently available drugs in acromegaly: long-acting somatostatin receptor ligands of the first generation (octreotide LAR and lanreotide autogel) and the second generation (pasireotide-LAR), as well as pegvisomant (PEG) and cabergoline (CAB).

News (Medical) associated with Octreotide depot (GP Pharm SA)

06 Mar 2025

·firstwordpharma.com

ITM fleshes out data for Phase III radiopharma success in neuroendocrine tumours

A radiopharmaceutical from ITM Isotope Technologies Munich reduced the risk of disease progression or death by 33% versus Novartis' targeted molecular therapy Afinitor (everolimus) in patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The outcome of the Phase III COMPETE study was first top-lined in January, with the announcement marking one of only a handful of wins for a radiopharmaceutical in a head-to-head trial. Detailed results were presented Thursday at the European Neuroendocrine Tumor Society (ENETS) annual meeting.The trial compared ITM-11 (177Lu-edotreotide) with Afinitor in 309 patients with inoperable, progressive Grade 1 or 2 somatostatin receptor (SSTR)-positive GEP-NETs. According to ITM, approximately 15% of people in each trial arm were treatment naïve, with the remaining 85% or so having received one prior therapy.Results showed that median progression-free survival (PFS) for ITM's therapeutic was 23.9 months, which was significantly and clinically better than the 14.1 months for Afinitor. In comparison, in the Phase III NETTER-2 trial, Novartis' peptide receptor radionuclide therapy Lutathera (lutetium Lu 177 dotatate) reduced the risk of disease progression or death by 72% as a first-line therapy for patients with SSTR-positive well-differentiated Grade 2/3 advanced GEP-NETs versus high-dose octreotide LAR alone, with median PFS in the two arms of 22.8 months and 8.5 months, respectively.ITM told FirstWord that the choice of Afinitor as a comparator in COMPETE was "backed by scientific evidence of efficacy and high clinical acceptance after market authorisation." The company suggested that this decision set "a higher standard for meeting the primary endpoint in more advanced grade tumours," adding that it hopes "physicians will recognise the higher threshold of our study design."FDA filing this year"These successful results validate our decision to design a pivotal Phase III trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy," CEO Andrew Carey said. Based on the findings, ITM plans to seek approval of ITM-11 in the US this year; however, the company told FirstWord that it is "currently prohibited" from filing in Europe until 2029 due to orphan drug designation on Lutathera.Top-line results also showed that interim median overall survival (OS) was 63.4 months for ITM-11. That was numerically higher than the 58.7 months seen with Afinitor, but not statistically significant at the current analysis. ITM noted that patients were allowed to start an alternative therapy after disease progression, "potentially confounding" the OS data."These data show unequivocal support for [ITM-11's] potential benefit in extending PFS," remarked study investigator Jaume Capdevila, adding that the radiopharmaceutical's "convenient dosing schedule and favourable safety results reinforce its potential as a compelling new treatment option."In COMPETE, patients were treated with ITM-11 every three months for up to four cycles, or with Afinitor daily for up to 30 months, or until disease progression. Meanwhile, ITM's therapy was well tolerated, with treatment-emergent adverse events occurring at a rate of 82.5%, compared with 97% for Afinitor. However, there was one Grade 2 event of myelodysplastic syndrome in the ITM-11 arm.Growing optionsNeuroendocrine tumours are one of the few cancers that have so far benefited from the approval of radiopharmaceuticals. Novartis currently markets Lutathera as a treatment for SSTR-positive GEP-NETs, while Sanofi also has skin in the game, having reached a deal last year to join forces with RadioMedix and Orano Med on the radioligand medicine AlphaMedix (212Pb-DOTAMTATE).Something that differentiates ITM from other players, however, is that it has worked in the radiopharma space for over 20 years and has manufacturing in-house. "Together, with our global isotopes manufacturing business, robust supply chain and experienced clinical and commercial team, we believe we are uniquely positioned as a standout leader in the fast-growing radiopharmaceutical industry," Carey said.ITM-11 — which combines the therapeutic β-emitting radioisotope lutetium-177 with the synthetic SSTR agonist edotreotide — is also being investigated in the Phase III COMPOSE trial in patients with well-differentiated, aggressive Grade 2 or 3 SSTR-positive GEP-NETs.

Phase 3Clinical ResultOligonucleotideOrphan Drug

22 Jan 2024

·www.pmlive.com

Novartis shares positive phase 3 results for Lutathera in neuroendocrine tumours

Novartis has shared positive results from a late-stage study of its radioligand therapy Lutathera (lutetium Lu 177 dotatate) as a first-line treatment for newly-diagnosed neuroendocrine tumours (NETs). The ongoing NETTER-2 trial has been evaluating Lutathera plus long-acting release (LAR) octreotide versus high-dose octreotide LAR alone in newly-diagnosed patients with grade two or three advanced gastroenteropancreatic neuroendocrine tumours (GEP-NETs) that are somatostatin receptor (SSTR)-positive. The incidence of NETs, a type of cancer that originates in neuroendocrine cells throughout the body, has increased over the past several decades. Despite being considered slow-growing malignancies, some NETS are associated with rapid progression and poor prognosis, and in many cases, diagnosis is delayed until patients are at an advanced stage. According to the results from NETTER-2, which were presented at this year’s American Society of Clinical Oncology Gastrointestinal Cancers Symposium, the Lutathera combination significantly extended progression-free survival to 22.8 months versus 8.5 months in the high-dose octreotide LAR cohort. No new or unexpected safety findings were observed in the study, Novartis said, adding that the trial will continue to assess secondary endpoints, including overall survival and long-term safety. Jeff Legos, global head of oncology development at Novartis, said: “This is the first positive phase 3 trial of a radioligand therapy in the first-line setting, and the overall efficacy and safety results are among the most clinically relevant observed to date in this kind of advanced cancer, addressing a significant unmet need for patients with newly-diagnosed advanced GEP-NETs. “The positive results are a significant advancement and further reaffirm our strategy to research and develop radioligand therapies in earlier lines of treatment or stages of disease to improve outcomes for patients.” Lutathera is already approved in the US to treat adult patients with SSTR-positive GEP-NETs and in Europe for adults with unresectable or metastatic, progressive, grade one or two SSTR-positive GEP-NETs. Lead study author, Dr Simron Singh, from the University of Toronto, said the results from NETTER-2 are “practice-changing” and “offer new first-line treatment data for patients who have a significant unmet need”. “These findings should instil confidence among physicians in using Lutathera as a first-line treatment for patients with this life-threatening type of cancer,” he said.

Clinical ResultPhase 3ASCOOligonucleotide

19 Jan 2024

·www.fiercepharma.com

Novartis eyes $1B Lutathera acceleration with trial win in newly diagnosed neuroendocrine tumors

The phase 3 win allows Novartis to "really move forward in educating the community" about Lutathera's benefits as a first-line therapy in certain neuroendocrine tumors, CEO Vas Narasimhan recently said. Novartis hopes new data will open a $1 billion market opportunity for its radioligand therapy, Lutathera, as a first-line treatment. Friday, the company’s ambition received a boost from the phase 3 readout of the NETTER-2 trial. In the study, Lutathera, plus long-acting release (LAR) octreotide, slashed the risk of disease progression or death by 72% versus high-dose octreotide LAR alone in newly diagnosed patients with grade 2 or 3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that are somatostatin receptor (SSTR)-positive. Patients in the Lutathera arm went a median 22.8 months without progression, compared with 8.5 months for those in the control arm. The data were shared at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium. The Lutathera results offer “a new, safe treatment option in a field with no established standard of care,” lead study author Simron Singh, M.D., from the University of Toronto said in a statement facilitated by ASCO. Lutathera’s current situation in the U.S. is a bit awkward. As Novartis CEO Vas Narasimhan noted during an investor call in October, Lutathera technically enjoys a broad indication that covers its first-line use in the U.S. Thanks to an FDA approval in 2018, the radioligand therapy can be used in SSTR-positive GEP-NETs regardless of a patient’s prior treatment history. But because the approval-enabling NETTER-1 trial was only conducted in patients with previously treated disease and in those with grade 1 and 2 tumors, the majority of Lutathera patients in the real world are getting the drug in the second line. “In the case of the U.S., we wouldn't need further label expansion,” Narasimhan said of the new NETTER-2 win. “And we plan to really move forward in educating the community on the importance of this data to move Lutathera into frontline setting.” A Novartis spokesperson confirmed to Fierce Pharma that the company won’t submit for a supplemental new drug application in the U.S. Outside the U.S., Novartis recently said it plans to file for a frontline grade 3 tumor indication in Europe this year. The spokesperson said the company isn’t able to offer more specific timings at this point. Novartis believes Lutathera could notch more than $1 billion in peak sales as a first-line therapy. In the first nine months of 2023, Lutathera chalked up $458 million in sales, good for growth of 34% growth year over year. By the Swiss pharma’s calculations, more than half of GEP-NET patients in the U.S. are treated in the first-line setting, compared with 30% in the second line and around 10% to 15% in the third line. The company estimates that the U.S. has about 170,000 NET patients, with roughly 55% to 70% of them being GEP-NET cases. Novartis needs to move fast, as the market for progressive NET is likely to get crowded. Exelixis and partner Ipsen recently celebrated positive phase 3 results for their drug Cabometyx in patients with previously treated NET arising in the pancreas or elsewhere. Exelixis is working with the Alliance for Clinical Trials in Oncology, which conducted the phase 3 study, to discuss a potential filing with the FDA this year, the California company said a few days ago. Besides Lutathera’s first-line use, Novartis is also focusing on a potential market expansion for another approved radioligand therapy, Pluvicto, which recently showed that it can stave off disease worsening when used before chemotherapy in PSMA-positive, metastatic castration-resistant prostate cancer. Still, unfavorable but immature survival data from the trial have forced the company to postpone an FDA filing pending a longer follow-up. Novartis figured the pre-chemo setting and a potential expansion in metastatic hormone-sensitive prostate cancer could together translate into more than $2 billion in peak sales for Pluvicto.

Phase 3Clinical ResultASCOOligonucleotide

100 Deals associated with Octreotide depot (GP Pharm SA)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acromegaly	Spain	GP Pharm SA	-
Bleeding esophageal varices	Spain	GP Pharm SA	-

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Intestinal Obstruction	Phase 2	France	Novartis Pharmaceuticals Corp.	01 Sep 2005
Peritoneal Neoplasms	Phase 2	France	Novartis Pharmaceuticals Corp.	01 Sep 2005
Advanced Prostate Carcinoma	Phase 2	Italy	Novartis AG	01 Feb 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Hemorrhage	-	Thalidomide	vbblkknvbd(locgborrvu) = Mild side effects (meteorism, nausea, exanthemas) were observed in these patients wgjvjynoqa (qeglrlksnp )	-	13 Oct 2024
NCT01538966 (CTgov)	Not Applicable	Acromegaly	76	Pegvisomant+Octreotide LAR+Lanreotide (High Dose SRL + Weekly Pegvisomant)	xqrwimqhry(rvgnjajyyi) = hosmfdwlsu xoemsrykfv (ebbnrtcfpx, 1,645.49) View more	-	04 Jan 2023
				Pegvisomant+Octreotide LAR+Lanreotide (Low Dose SRL + Daily Pegvisomant)	xqrwimqhry(rvgnjajyyi) = xdiglfpgdq xoemsrykfv (ebbnrtcfpx, 11,158.49) View more
Pubmed \| PLoS One	Phase 2	Thymus Neoplasms Neoadjuvant positive octreotide scans	17	Octreotide LAR	dxtcsnzwcs(ydcbhqcsec) = 71% ifdcvmordq (kzecwqfpsh ) View more	Positive	16 Dec 2016
NCT01371643 (CTgov)	Phase 4	Pituitary Adenoma \| Acromegaly	41	Octreotide LAR (Medical Treatment by Octreotide LAR)	kixgqacnwz = zvqozsuyuj babrgfvwwq (plczglvoes, akrnezlqcr - aoprzogdce) View more	-	22 Jul 2016
				transsphenoidal surgery+Octreotide LAR (Surgical Debulking Followed by Octreotide LAR)	kixgqacnwz = fnfcjglaxk babrgfvwwq (plczglvoes, hhybyuayvb - ieetprbvkw) View more
NCT00332696 (CTgov)	Phase 2	Intestinal Obstruction \| Peritoneal Neoplasms	64	Octreotide (Immediate release)+methylprednisolone+Octreotide LAR (Octreotide)	npygcwwnoi = lqivtcnzmf cmpykirhwk (llsqusudtt, rkkesiejfc - kfabgwlihh) View more	-	15 Jun 2011
				Placebo+methylprednisolone (Placebo)	npygcwwnoi = zasewinjvp cmpykirhwk (llsqusudtt, geaahvkzkg - nvuosggaua) View more
N00CA (Pubmed \| J Clin Oncol)	Phase 3	Acute diarrhea	125	Depot octreotide	sjrgwgacxr(xlfoaindui) = lqihqvjnrb wgziapikuk (xydqcrseed ) View more	Negative	10 Nov 2008
				Placebo	sjrgwgacxr(xlfoaindui) = rrlpwgqckh wgziapikuk (xydqcrseed ) View more
NCT00616408 (Pubmed \| Clin Endocrinol (Oxf))	Not Applicable	Acromegaly	98	Octreotide LAR 10-30 mg	ggodglzqpn(dprosghmft) = pcnhzudwpl heqwpbtmkg (pqvocnrtyu )	-	01 Jun 2007
NCT00616408 \| NCT00461149 (Pubmed \| J Clin Endocrinol Metab)	Phase 4	Acromegaly	67	Octreotide LAR	lghkqlvlbi(hzutpngrra) = bmklglyloi aqvifbxtas (cpdghgxork )	-	01 Apr 2006

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