Clinical phase III study of YP-18 for febrile neutropenia

Phase 3

• Conditions: Febrile neutropenia

• Registration Number: JPRN-jRCT2080221686
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 110

Inclusion Criteria

[Start of pre-observation period] Patients satisfying all the following criteria:
(1) Patients diagnosed as histologically or cytologically malignant solid tumor or hematopoietic organ tumor
(2) Patients expected to undergo or undergoing the treatment with anticancer drug or hematopoietic stem cell transplantation (only for patients undergoing autologous transplantation), who are expected to induce febrile neutropenia during the treatment
(3) Patients aged 9 months or older (at acquisition of consent)
(4) Patients expected to survive during participation in the study

[At start of administration of the study drug] Subjects satisfying all the following criteria:
(1) Subjects satisfying the following criteria:
1) The body temperature (axillary temperature) determined before administration of the study drug is 38 or higher, or the fever of 37.5 or higher of unknown cause continues for more than 1 hour
2) The neutrophil count before start of administration of the study drug is less than 500/mm3, or less than 1000/mm3 which is expected to reduce to less than 500/mm3
(2) Subjects satisfying the following criteria based on the data within 7 days before start of administration of the study drug:
1) In the hepatic functions, either of AST(GOT) or ALT(GPT) does not exceed 5 times as large as the upper limit of institutional standard value, or the total bilirubin does not exceed 1.5 times as large as the upper limit of institutional standard value.
2) In the renal functions, the serum creatinine value does not exceed 1.5 times as large as the upper limit of institutional standard value, and in adults, the estimated value for creatinine clearance is not less than 40 mL/min.
In the absence of standard value for serum creatinine in children by age in the institution concerned, moreover, it does not exceed 1.5 times as large as the upper limit of standard value with reference to the standard value for serum creatinine in children by age established by the Japanese Society for Pediatric Nephrology.
(3) Hospitalized patients (however, can be discharged from hospital after the post-observation period)

Exclusion Criteria

[At start of pre-observation period] Patients falling into any of the following criteria:
(1) Patients with a history of allergy or serious adverse reaction to the ingredients of study drug and beta-lactam antimicrobial drug
(2) Patients with infectious mononucleosis
(3) Patients who have undergone the treatment of study drug after giving the consent for this clinical study (reenrollment is permissible unless YP-18 has been administered despite of giving the consent for this clinical study)
(4) Patients who participated in the other clinical studies within the past 28 days
(5) Patients considered by the investigator or subinvestigator to be unsuitable as the subject of the clinical study

[At start of administration of the study drug] Subjects falling into any of the following criteria:
(1) Subjects considered that the pretreatment with other antimicrobial drug, antifungal drug, antiviral drug, etc. is effective for the episode of existing febrile neutropenia and the symptoms are already improving. Not applicable if the pretreatment is considered ineffective, however. Moreover, the subjects receiving Zosyn for Intravenous Injection (tazobactam sodium/piperacillin sodium) should be excluded irrespective of the presence or absence of efficacy.
(2) Patients with infections with the pathogens insusceptible to this drug or resistant strains, including MRSA, fungi, viruses, etc. and considered to have difficulty in expecting the efficacy of this drug
(3) Pregnant women, lactating women, or women with the possibility of pregnancy
(4) Subjects considered by the investigator or subinvestigator to be unsuitable for the clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antipyretic effect<br>Antipyretic effect

Secondary Outcome Measures

Name	Time	Method
Efficacy, Safety, Pharmacokinetics<br>CTCAE (ver.4.03)