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

NCT04472143 | Unknown Phase 2

• 1 other identifier: SS-SP01-201904
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

oral anticancer agents

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects achieving complete response of nausea and vomiting (complete response is defined as no vomiting and/or retching, and no rescue medication) within 7 days after administration

  complete response means no vomiting, and no rescure medication (day 1-7)

  7 days

Secondary Outcomes (6)

• The percentage of subjects achieving complete response of nausea and vomiting on days 1-3 (acute phase) and on days 4-7 (delayed phase) after administration

  7 days

• The percentage of subjects achieving complete control of nausea and vomiting (complete control is defined as no vomiting and/or retching, no more than mild nausea, and no rescue medication) within 7 days after administration

  7 days

• The percentage of subjects achieving complete control of nausea and vomiting on days 1-3 (acute phase) and on days 4-7 (delayed phase) after administration

  7 days

• Patients' satisfaction with antiemetic therapy (assessed using a 10-cm visual analog scale at the time of patch removal）

  7 days

• The frequency of vomiting episodes per day after the administration of oral chemotherapy during the observation period (the oral chemotherapy initiation until 24 h after patch removal)

  7 days

Study Arms (1)

Granisetron Transdermal Delivery System

EXPERIMENTAL

The patch will be applied to the upper arm 24-48 hours before the start of chemotherapy, and left in place for 7 days

Drug: Granisetron Transdermal Delivery System

Interventions

Granisetron Transdermal Delivery System DRUG

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.

Also known as: sancuso; granisetron transdermal patch

Granisetron Transdermal Delivery System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged ≥ 18 years;
• Histologically and/or cytologically confirmed locally advanced/metastatic breast cancer;
• The physical status score ECOG ≤ 2；
• Life expectancy of ≥3 months;
• Will receive the first treatment cycle of oral pirotinib combined with capecitabine;
• 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
• Subjects voluntarily participate and signed the informed consent form.

You may not qualify if:

• Contraindicated to 5-HT receptor antagonists (such as gastrointestinal obstruction) or allergy to 5-HT;
• Any nausea and vomiting (II or above) within 72 hours before the start of chemotherapy;
• Prolonged QT interval at baseline (QTc\>470msec at baseline);
• Patients scheduled to receive radiotherapy of whole body, brain or upper abdomen;
• Confirmed by craniocerebral CT or MRI, patients with brain tumor lesions or patients taking drugs to treat brain tumors or epileptic symptoms;
• Patens unable to cooperate and describe treatment response;
• History of drug abuse and alcohol dependence;
• Pregnancy, lactation or intended pregnancy;
• History of allergic reactions to drugs with similar chemical structures, or to transdermal therapeutic systems, including commercial dressings such as Elastoplast®
• 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;
• Unable to eat for any reason;
• Other situations evaluated by investigators as unsuitable for enrollment.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

Related Publications (2)

• Coluzzi F, Mattia C. Management of chemotherapy-induced nausea and vomiting in patients receiving multiple-day highly or moderately emetogenic chemotherapy: role of transdermal granisetron. Future Oncol. 2016 Aug;12(16):1865-76. doi: 10.2217/fon-2016-0097. Epub 2016 May 17.

  PMID: 27184113 BACKGROUND

• Navari RM, Aapro M. Antiemetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Apr 7;374(14):1356-67. doi: 10.1056/NEJMra1515442. No abstract available.

  PMID: 27050207 BACKGROUND

MeSH Terms

Conditions

Vomiting

Interventions

Granisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xichun Hu, Prof.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XiChun Hu, Prof.

CONTACT

64175590; huxicun@gmail.com

Biyun Wang, Prof.

CONTACT

64175590; pro_wangbiyun@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 15, 2020
• Study Start: July 18, 2020
• Primary Completion: September 18, 2022
• Study Completion: December 31, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)