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

• Status: Not yet recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Granisetron

Criteria

Inclusion Criteria:

1. Female aged ≥ 18 years;

2. Histologically and/or cytologically confirmed locally advanced/metastatic breast cancer;

3. The physical status score ECOG ≤ 2；

4. Life expectancy of ≥3 months;

5. Will receive the first treatment cycle of oral pirotinib combined with capecitabine;

6. In accordance with the indication of chemotherapy and basic requirements;

• Peripheral haematology: Hb ≥9.0g/dL; absolute neutrophil count ≥1.5×109/L；platelet count ≥80×109/L

• Blood biochemistry: Total bilirubin < 1.25×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST < 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca)

• Other important organs function normally

7. Subjects voluntarily participate and signed the informed consent form.

Exclusion Criteria:

1. Contraindicated to 5-HT receptor antagonists (such as gastrointestinal obstruction) or allergy to 5-HT;

2. Any nausea and vomiting (II or above) within 72 hours before the start of chemotherapy;

3. Liver and kidney diseases, infections, and diseases of central nervous system or mental health. Patients who are evaluated by investigators as unsuitable for inclusion;

4. Prolonged QT interval at baseline (QTc>470msec at baseline);

5. Patients scheduled to receive radiotherapy of whole body, brain or upper abdomen;

6. Confirmed by craniocerebral CT or MRI, patients with brain tumor lesions or patients taking drugs to treat brain tumors or epileptic symptoms;

7. Patens unable to cooperate and describe treatment response;

8. History of drug abuse and alcohol dependence;

9. Pregnancy, lactation or intended pregnancy;

10. History of allergic reactions to drugs with similar chemical structures, or to transdermal therapeutic systems, including commercial dressings such as Elastoplast®

11. Those who have participated or plan to participate in other clinical trials of granisetron; those who have participated in other clinical trials within 30 days before enrollment;

12. Unable to eat for any reason;

13. Other situations evaluated by investigators as unsuitable for enrollment.