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Granisetron Transdermal Patch for Prophylaxis of Nausea and Vomiting in Patients Receiving Oral Anticancer Agents

NCT04472143 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-20

No results posted yet for this study

Summary

At present, the clinical studies of 5-HT3RA are aimed at nausea and vomiting induced by single-day chemotherapy, but there are many chemotherapy schemes that require multi-day administration in clinical practice. Compared with single-day chemotherapy, multi-day chemotherapy (including multi-day intravenous chemotherapy and multi-day administration of oral antineoplastic drugs) faces a more complex situation, requiring the prevention of both acute CINV, and delayed CINV at the same time. Clinically, oral or intravenous 5-HT3 antagonists are needed for many times, and the convenience is poor. Especially with the increasing application of oral antineoplastic drugs (including oral chemotherapeutic drugs and oral molecular targeted drugs), the nausea and vomiting caused by oral antineoplastic drugs have attracted more and more attention of clinicians. Pyrotinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4.12 Preclinical data suggest that pyrotinib can irreversibly inhibit multiple ErbB receptors and effectively inhibit the proliferation of HER2-overexpressing cells both in vivo and in vitro. Pirotinib is an effective drug that progresses after treatment with trastuzumab. At present, pirrotinib combined with capecitabine has made a major breakthrough in the treatment of recurrent and metastatic HER-positive breast cancer, with a median PFS of 18.1 months and an ORR of 78.5%. Although most adverse reactions are controllable, the program The incidence of related nausea and vomiting has reached about 50%, and nausea and vomiting most often occurred in the first week after treatment, which not only affected the patient's quality of life, but also affected the treatment compliance of the two oral drugs to a certain extent. It has become a more difficult problem for clinicians in the treatment process.

Conditions

  • Chemotherapy-induced Nausea and Vomiting (CINV)

Interventions

DRUG

Granisetron Transdermal Delivery System

A total of 60 patients with HER2-positive advanced breast cancer who are scheduled to receive pirotinib combined with capecitabine will be enrolled. A single transdermal patch will be applied to the subject' upper outer arm 24-48 hours before chemotherapy for 7 days. The observation period will be from the time of enrollment to 14 days (± 7 days) after the removal of granisetron patch.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xichun Hu, Prof. · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-18
Primary Completion
2022-09-18
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04472143 on ClinicalTrials.gov