granisetron oral / Generic mfg. - LARVOL DELTA

Granisetron as a Novel Treatment for Acute Food Protein-induced Enterocolitis Syndrome. (PubMed, JMA J) - "Our case series aimed to evaluate the effectiveness and safety of intravenous granisetron in acute FPIES episodes...Given the limited evidence on granisetron for FPIES, accumulating case reports is essential for guiding clinical trials and regulatory approval. Further comparative studies of granisetron and ondansetron are warranted."

Journal • Allergy • Food Hypersensitivity • Gastrointestinal Disorder • Immunology

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P3 | N=72 | Active, not recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Sep 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • Renal Disease

Oral Akynzeo® Vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (clinicaltrials.gov) - P4 | N=414 | Completed | Sponsor: Helsinn Healthcare SA | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024

Trial completion • Trial completion date • Chemotherapy-Induced Nausea and Vomiting

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (clinicaltrials.gov) - P4 | N=414 | Active, not recruiting | Sponsor: Helsinn Healthcare SA | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2024 ➔ Jul 2024

Enrollment closed • Trial primary completion date • Chemotherapy-Induced Nausea and Vomiting

Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group (clinicaltrials.gov) - P=N/A | N=160 | Completed | Sponsor: Ain Shams University

New trial • Gastroenterology • Gastrointestinal Disorder • Pediatrics

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P3 | N=72 | Recruiting | Sponsor: University of Colorado, Denver | Phase classification: P=N/A ➔ P3 | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Sep 2023 ➔ Sep 2025

Phase classification • Trial completion date • Trial primary completion date • Renal Disease

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (clinicaltrials.gov) - P4 | N=530 | Recruiting | Sponsor: Helsinn Healthcare SA | Trial completion date: Aug 2023 ➔ Nov 2024 | Trial primary completion date: Apr 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Chemotherapy-Induced Nausea and Vomiting

5-HT3 Antagonist Antiemetic Drugs Alter Cisplatin Pharmacokinetics and Risk of Nephrotoxicity (KIDNEY WEEK 2022) - P=N/A | "Methods As part of study NCT03817970, an initial group of patients (n=23) undergoing their first or second round of cisplatin chemotherapy (≥25 mg/m 2 ) were prospectively randomized to one of three antiemetic drugs (ondansetron 8 mg p.o., granisetron 2 mg p.o., or palonosetron 0.25 mg i.v.). Conclusion Cisplatin-treated cancer patients prescribed ondansetron for the prevention of emesis exhibited decreased kidney function when compared to patients receiving granisetron or palonosetron. Future work will expand analyses to include additional patients, urinary excretion of cisplatin, and urinary biomarkers of kidney injury."

PK/PD data • Acute Kidney Injury • Nephrology • Oncology

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P=N/A | N=72 | Recruiting | Sponsor: University of Colorado, Denver | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Sep 2022 ➔ Sep 2023

Trial completion date • Trial primary completion date • Renal Disease

Tick-borne Encephalitis and Borrelial Antibodies in Serum (clinicaltrials.gov) - P=N/A | N=80 | Recruiting | Sponsor: University Medical Centre Ljubljana | Trial completion date: Dec 2021 ➔ Dec 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2023

Trial completion date • Trial primary completion date • CNS Disorders • Lyme Disease

[VIRTUAL] Phase II Trial of Antiemetic Oral Granisetron Plus Dexamethasone for Nausea and Vomiting Caused by Crizotinib in ALK or ROS1 Fusion - Positive NSCLC (IASLC-WCLC 2021) - "Conclusion The double combination of oral granisetron plus dexamethasone is the valid prophylactic regimen for nausea and vomiting caused by crizotinib in patients with ALK or ROS1-positive NSCLC. Clinical trial information: jRCTs031180378."

P2 data • CNS Disorders • Constipation • Gastroenterology • Gastrointestinal Disorder • Insomnia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Sleep Disorder • Solid Tumor • ALK • MET • ROS1

Oral Akynzeo® vs Standard of Care in Preventing CINV in High-risk MEC Patients (MyRisk) (clinicaltrials.gov) - P4; N=530; Recruiting; Sponsor: Helsinn Healthcare SA

Clinical • New P4 trial • Chemotherapy-Induced Nausea and Vomiting

Transdermal versus oral granisetron in controlling chemotherapy-induced nausea and vomiting: a meta-analysis. (PubMed, Support Care Cancer) - "Oral granisetron is better in achieving complete control of CINV in patients receiving chemotherapy. As for the risk of constipation and QTc prolongation as adverse effects, there was no statistically significant difference between the two routes."

CINV • Journal • Retrospective data • Review • Chemotherapy-Induced Nausea and Vomiting • Constipation • Gastrointestinal Disorder • Oncology

Transdermal granisetron for the prevention of nausea and vomiting following moderately or highly emetogenic chemotherapy in Chinese patients: a randomized, double-blind, phase III study. (PubMed) - Chin Clin Oncol - "GTDS provided effective and well-tolerated control of CINV in Chinese patients, especially to non-cisplatin-contained regimen."

Journal • Biosimilar • Oncology

A phase III study of transdermal granisetron versus oral ondansetron for women with gynecologic cancers receiving pelvic chemoradiation. (PubMed, Support Care Cancer) - "Transdermal granisetron was 82% more like to control CINV than oral ondansetron in the late phase of cycle 1 and performed similarly to oral ondansetron in all other cycles. Transdermal granisetron should be considered an option as prophylactic antiemetic therapy for gynecologic cancer survivors undergoing chemoradiation."

Clinical • Journal • P3 data • Cervical Cancer • Chemotherapy-Induced Nausea and Vomiting • Endometrial Cancer • Gynecologic Cancers • Oncology • Palliative care • Solid Tumor • Uterine Cancer • Vaginal Cancer

PTX-200 and Carboplatin in Ovarian Cancer (clinicaltrials.gov) - P1a/1b; N=15; Terminated; Sponsor: Prescient Therapeutics, Ltd.; N=36 ➔ 15; Active, not recruiting ➔ Terminated; Lack of enrollment

Clinical • Enrollment change • Trial termination

PTX-200 and Carboplatin in Ovarian Cancer (clinicaltrials.gov) - P1a/1b; N=36; Active, not recruiting; Sponsor: Prescient Therapeutics, Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P=N/A; N=72; Recruiting; Sponsor: University of Colorado, Denver; Not yet recruiting ➔ Recruiting; Trial primary completion date: Dec 2022 ➔ Sep 2022

Enrollment open • Trial primary completion date

Pharmacokinetics and safety of transdermal and oral granisetron in healthy Chinese subjects: An open-label, randomized, crossover study. (PubMed, Int J Clin Pharmacol Ther) - "The C values determined through TD and OA were equivalent, indicating similar drug exposures. Therefore, the granisetron patch may be an alternative formulation for oral granisetron in Chinese individuals.."

Clinical • Journal • PK/PD data

AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies (clinicaltrials.gov) - P1; N=48; Completed; Sponsor: AstraZeneca; Active, not recruiting ➔ Completed; Trial completion date: Mar 2020 ➔ May 2019; Trial primary completion date: Mar 2020 ➔ May 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

Effects of AZD1775 on the PK Substrates for CYP3A, CYP2C19, CYP1A2 and on QT Interval in Patients With Advanced Cancer (clinicaltrials.gov) - P1; N=33; Completed; Sponsor: AstraZeneca; Active, not recruiting ➔ Completed

Clinical • PK/PD data • Trial completion

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P=N/A; N=72; Not yet recruiting; Sponsor: University of Colorado, Denver; Initiation date: Jan 2019 ➔ Apr 2019

Trial initiation date

AZD1775 Continued Access Study to Assess Safety and Tolerability for Patients Enrolled in AZD1775 Clinical Pharmacology Studies (clinicaltrials.gov) - P1; N=48; Active, not recruiting; Sponsor: AstraZeneca; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2020 ➔ Mar 2020; Trial primary completion date: Aug 2020 ➔ Mar 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

PTX-200 and Carboplatin in Ovarian Cancer (clinicaltrials.gov) - P1a/1b; N=36; Recruiting; Sponsor: Prescient Therapeutics, Ltd.; Trial completion date: Dec 2018 ➔ Dec 2019; Trial primary completion date: Dec 2018 ➔ Dec 2019

Clinical • Trial completion date • Trial primary completion date

Cisplatin Disposition and Kidney Injury (clinicaltrials.gov) - P=N/A; N=72; Not yet recruiting; Sponsor: University of Colorado, Denver

New trial