Safety of a short-term infusion of fosnetupitant

JRCT ID: jRCT1041220144

Registered date:17/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Solid tumor
• Date of first enrollment: 22/02/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Patients will be Administered fosnetupitant 235 mg in 15 minutes.

Outcome(s)

• Primary Outcome: Incidence of allergic reaction when fosnetupitant was administered for the first time at 15 minutes.

Secondary Outcome

- Incidence of ISR (CTCAE v5.0 grade >= 1)
- Incidence of adverse events other than allergic reactions (CTCAE v5.0 grade >=3)
- Complete response rate over the entire period (0 to 120 hours after HEC or MEC administration)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with solid tumors who have received fosnetupitant and are scheduled to receive it continuously.
2)The age of patients on registration date is 18 years or older.
3)ECOG PS 0,1 or 2.
4)Patients whose latest test values within 28 days before registration(CTCAE v5.0) meet all of the following.
(1)AST(GOT) Grade <=1
(2)ALT(GPT) Grade <=1
(3)Total bilirubin Grade <=1
5)Patients who are able to comply with the protocol requirements
6)Patients who have voluntarily given written consent after understanding the content of the informed consent document

Exclude criteria

1)Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, uncontrolled hypertension, uncontrolled diabetes, etc.)
2)Patients with serious infections (including active tuberculosis)
3)Patients with a history of allergic reactions of grade 3 or higher with CTCAE v5.0 to systemic therapy in the past
4)Patients with a history of allergic reactions to fosnetupitant administered for 30 minutes
5)Patients with severe allergic disease requiring continuous administration of antiallergic drugs or steroids
6)Pregnant women, female patients who are breastfeeding or may be pregnant
7)Patients who are not willing to use contraception
8)Patients judged by the investigator to be inappropriate

Related Information

• Primary Sponsor: Narita Yukiya