Phase 1b/3 Global, Randomized, Controlled, Open-label Trial Comparing Treatment With RYZ101 to Standard of Care Therapy in Subjects With Inoperable, Advanced, SSTR+, Well-differentiated GEP-NETs That Have Progressed Following Prior 177Lu-SSA Therapy

This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity [HA]-DOTATATE.

开始日期2022-03-24

申办/合作机构

Rayzebio, Inc.初创企业

NCT03375320 / Active, not recruiting临床3期IIT

Randomized, Double-Blinded Phase III Study of CABozantinib Versus Placebo IN Patients With Advanced NEuroendocrine Tumors After Progression on Prior Therapy (CABINET)

This phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.

开始日期2018-10-26

申办/合作机构

National Cancer Institute

NCT02831179 / Withdrawn临床1期IIT

A Phase 1 Study of Veliparib (ABT-888) in Combination With Capecitabine and Temozolomide in Advanced Well-Differentiated Neuroendocrine Tumors

This phase I trial studies the side effects and best dose of veliparib when given together with capecitabine and temozolomide in treating patients with neuroendocrine tumor that has spread to other places in the body and usually cannot be cured or controlled with treatment, has returned after a period of improvement, and cannot be removed by surgery. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

开始日期2017-12-01

申办/合作机构

The Vanderbilt-Ingram Cancer Center

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2023-09-01·Best Practice & Research Clinical Endocrinology & Metabolism

Established and novel circulating neuroendocrine tumor biomarkers for diagnostic, predictive and prognostic use

Review

作者: Angelousi, Anna ; Koumarianou, Anna ; Tsoli, Marina ; Kaltsas, Gregory

The management of neuroendocrine tumors (NETs) represents a clinical challenge due to heterogeneity of their clinical behaviour, molecular biology and response to treatment. Over the years, several circulating biomarkers have been developed for the early diagnosis and follow-up of NETs. The specific secretory products of tumors associated with a secretory syndrome (functioning tumors) may be used as diagnostic and/or prognostic biomarkers while the most common non-specific circulating biomarkers, that may be increased in both functioning and non-functioning tumors, are chromogranin A and the neuron specific enolase. However, the diagnostic accuracy as well as the prognostic and predictive value of these biomarkers are limited and novel techniques of multianalyte analysis of regulators of tumor biology have been developed. The NETest has been most extensively studied and proved to be useful in NET diagnosis, early detection of post-operative recurrence and prediction of response to treatment but further investigation establishing higher level of evidence is required for implementation in clinical practice.

2023-09-01·Best Practice & Research Clinical Endocrinology & Metabolism

Effective strategies for adequate control of hormonal secretion in functioning neuroendocrine neoplasms

Review

作者: Hofland, Johannes ; de Herder, Wouter W

Neuroendocrine neoplasms are a unique form of malignancies as they can be accompanied by specific functioning hormonal syndromes that can impair survival and quality of life in patients. Functioning syndromes are defined by the combination of specific clinical signs and symptoms in combination with inappropriately elevated circulating levels of hormones. Clinicians should remain vigilant for the presence of functioning syndromes in neuroendocrine neoplasm patients at presentation as well as during follow-up. The correct diagnostic work-up should be initiated in cases of clinical suspicion of a neuroendocrine neoplasm-associated functioning syndrome. Management of a functional syndrome includes options from supportive, surgical, hormonal and antiproliferative treatment modalities. Here, we review the patient and tumour characteristics for each functioning syndrome that should be taken into account when deciding the optimum treatment strategy in neuroendocrine neoplasm patients.

2022-05-01·International Journal of Surgery Case Reports

Acute intestinal pseudo-obstruction by pheochromocytoma: A case report with review of literature

Article

作者: Kakamad, Fahmi H ; Ahmed, Shaho F ; Buchholz, Noor ; Salih, Abduwahid M ; Qader, Deedar ; Popov, Elenko ; Bapir, Rawa ; Gharib, Soran Mohammeed

INTRODUCTIONPheochromocytomas are rare tumors of the adrenal gland. Intestinal pseudo-obstruction is a very rare presentation of a functioning catecholamine-secreting tumor. We present a case of intestinal pseudo-obstruction due to a large functioning pheochromocytoma.CASE REPORTA 29-year-old female presented with abdominal distension, pain, nausea, and vomiting with constipation for 3 weeks. She was hypertensive and diabetic and was on multiple medications. She reported frequent spells of severe headaches, palpitations, night sweats, and a 17 kg weight loss over 6 months. She had pallor, dyspnea, marked abdominal distension, and diminished bowel sounds. Her blood pressure was high at 200/120 mmHg. She had tachycardia (pulse 120 bpm) and tachypnea (35 pm). Serum metanephrine levels were significantly elevated, measuring 1203 pg/ml. Abdominal CT showed a heterogeneous, hyper-vascular mass near the upper pole of the left kidney, measuring 10.75 cm × 8.72 cm. Open left adrenalectomy was performed through an anterior subcostal approach to remove the tumor with the left adrenal gland. Histopathological examinations were consistent with pheochromocytoma.DISCUSSIONSome authors documented the correlation between tumor size and metabolic activity of catecholamine-secreting tumors with intestinal pseudo-obstruction by paralytic ileus. This case corresponds with these findings, with a tumor mass of 350 g and a serum metanephrine level of 1203 pg/ml.CONCLUSIONAlthough it is extremely rare, functioning pheochomocytoma could be a cause of instestinal obstruction or pseudo-obstruction.