Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Breast Neoplasms

Nausea

Vomiting

Breast Diseases

Skin Diseases

Signs and Symptoms, Digestive

Acute Graft Versus Host Disease

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Fosaprepitant

Aprepitant

Granisetron

Serotonin

Serotonin 5-HT3 Receptor Antagonists

Neurotransmitter Agents

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Patients receive granisetron transdermal system patch 24-48 hrs before the initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7 days. Patients receive fosaprepitant dimeglumine IV over 15 minutes on day 1 of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of unacceptable toxicity.

Given granisetron transdermal system patch

granisetron transdermal system

fosaprepitant dimeglumine

laboratory biomarker analysis

Agustin Garcia

This clinical trial studies how well fosaprepitant dimeglumine and granisetron transdermal system work in preventing nausea and vomiting in patients with breast cancer undergoing chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy

PRIMARY OBJECTIVE:

I. To evaluate the efficacy of the combination of fosaprepitant (fosaprepitant dimeglumine) and granisetron transdermal system in the prevention of acute and delayed chemotherapy induced nausea and vomiting in breast cancer patients undergoing adjuvant or neoadjuvant chemotherapy.

SECONDARY OBJECTIVE:

I. To evaluate the safety of the combination of fosaprepitant and granisetron transdermal system in breast cancer patients undergoing adjuvan or neoadjuvant chemotherapy.

EXPLORATORY OBJECTIVE:

I. To explore the use of single nucleotide polymorphisms (SNPs) in the 5âhydroxytryptamine-3 (5HT3) and neurokinin-1 (NK-1) receptors as potential markers of efficacy.

OUTLINE: Patients receive granisetron transdermal system patch 24-48 hrs before the initiation of chemotherapy. Patients wear the granisetron transdermal system patch for 7 days. Patients receive fosaprepitant dimeglumine intravenously (IV) over 15 minutes on day 1 of chemotherapy. Treatment repeats every 2 or 3 weeks for up to 4 courses in the absence of unacceptable toxicity.

Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy

A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response

The complete response rate with the exact 95% confidence intervals (CIs) will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.

The complete response rate with the exact 95% CIs will be calculated. The associations between the complete response rate and patient characteristics and biomarkers will be examined using Fisherâs exact test or Mann-Whitney U test whenever appropriate.

National Cancer Institute (NCI)

University of Southern California

Oculocerebral Syndrome With Hypopigmentation

Granisetron IV

The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.

Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years

An Open-label, Cross-over, Pharmacokinetic Study to Assess the Safety and Pharmacokinetics of Transdermal Granisetron (Sancuso® Patch) and IV Granisetron in a Pediatric Oncology Population (Aged 13 to 17 Years)

Analysis of the plasma concentration of Intravenous granisetron vs transdermal granisetron in pediatric patients receiving chemotherapy over two sequential cycles.

Safety: based on medical review of adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs)

Kyowa Kirin Pharmaceutical Development Ltd

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy	NCT01649258	Breast Cancer Nausea Vomiting	granisetron tra... fosaprepitant d... laboratory biom...	18 Years -	University of Southern California
Fosaprepitant Dimeglumine and Granisetron Transdermal System in Preventing Nausea and Vomiting in Patients With Breast Cancer Undergoing Chemotherapy	NCT01649258	Breast Cancer Nausea Vomiting	granisetron tra... fosaprepitant d... laboratory biom...	18 Years -	University of Southern California
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years	NCT01596400	Chemotherapy In...	granisetron tra... Granisetron IV	13 Years - 17 Years	Kyowa Kirin Pharmaceutical Development Ltd

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