Randomized open label study about the injection site reaction of aprepitant and fosaprepitant meglumine in the PTX and CBDCA plus or minus Bev therapy for gynecologic tumor.

Randomized open label study about the injection site reaction of aprepitant and fosaprepitant meglumine in the PTX and CBDCA plus or minus Bev therapy for gynecologic tumor. - Randomized open label study about the injection site reaction of aprepitant and fosaprepitant meglumine in the PTX and CBDCA plus or minus Bev therapy for gynecologic tumor.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019053

Enrollment

100

Registered

2015-10-01

Start date

2016-03-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gynecologic tumor

Interventions

Subjects are administered the Fosaprepitant Meglumine 150mg on the first day of each course. It will be up to 6 courses. Subjects are administered the Aprepitant 125mg on the first day and 80mg on th

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Upon participation in the present study, patients who obtained the document consent of free will of the person on a thorough understanding after receiving a sufficient explanation Patients who have been diagnosed with gynecologic tumor Patients undergoing the first chemotherapy

Exclusion criteria

Exclusion criteria: Patients admitted the expression of injection site reaction-like symptoms within antineoplastic agent administered before the start of 24 hours Patients admitted nausea and vomiting within the antineoplastic agents administration before the start of 24 hours In addition, patients who are determined to be unsuitable as a target by principal investigator or research division

Design outcomes

Primary

Measure	Time frame
The grade of injection site reaction	—

Secondary

Measure	Time frame
Distribution of the injection site reaction incidence at each course Incidence and the grade of the adverse event with the PTX and CBDCA plus or minus Bev therapy	—

Countries

Japan

Contacts

Public ContactSeira,Yosuke Nishibe,Ando

Fujita Health University Department of Pharmacotherapeutics and Informatics

isr.fosaprepitant2015@gmail.com0562-93-2157

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026