UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054933 |
|---|---|
| Receipt number | R000062756 |
| Scientific Title | Zolbetuximab-Induced Nausea and Vomiting: A multicenter interventional study |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/09 17:22:38 |
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Basic information
Public title
Zolbetuximab-Induced Nausea and Vomiting: A multicenter interventional study
Acronym
ZOL-INVEST - Zolbetuximab-Induced Nausea and Vomiting Evaluation Study
Scientific Title
Zolbetuximab-Induced Nausea and Vomiting: A multicenter interventional study
Scientific Title:Acronym
ZOL-INVEST - Zolbetuximab-Induced Nausea and Vomiting Evaluation Study
Region
| Japan |
Condition
Condition
HER2-negative, Claudin-positive unresectable advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the actual infusion rates of Zolbetuximab and the occurrence of nausea and vomiting requiring infusion interruption or rate adjustment for each prophylactic antiemetic (pre-medication) when Zolbetuximab-containing chemotherapy is administered for unresectable advanced or recurrent gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The infusion rate at which Grade 2 or higher nausea/vomiting (requiring infusion interruption or rate adjustment) first occurs during the first cycle.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Initiate the first administration of Zolbetuximab at 100 mg/m2/h and increase the infusion rate to 200 mg/m2/h, 300 mg/m2/h, and 400 mg/m2/h
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients with HER2-negative, Claudin-positive unresectable advanced or recurrent gastric cancer who are scheduled to receive Zolbetuximab-containing cancer chemotherapy for the first time
- Patients with no history of chemotherapy with moderate emetic risk and high emetic risk anticancer drugs
- Patients scheduled to receive antiemetic therapy that includes at least three drugs: 5-HT3RA, NK1RA, and dexamethasone as prophylactic antiemetic therapy
- Patients who can accurately maintain a patient diary
- Patients aged 20 years or older on the registration date
- Latest laboratory values within 2 weeks before registration meeting all of the following criteria:
- Total bilirubin (T-bil) <= 2.0 mg/dL
- Aspartate aminotransferase (AST) <= 100 U/L
- Alanine aminotransferase (ALT) <= 100 U/L
- Creatinine clearance (CCr) >= 45 mL/min
Key exclusion criteria
- Patients who start Zolbetuximab at a reduced dose
- Patients with nausea (Grade 2) requiring antiemetic treatment at the time of registration
- Patients with vomiting at the time of registration
- Patients who started narcotic medications (strong opioids) within 48 hours before registration
- Patients with ascites requiring therapeutic paracentesis
- Patients with symptomatic brain metastasis and carcinomatous meningitis
- Patients with gastrointestinal disorders such as bowel obstruction
- Patients who have received radiation therapy to the abdomen (below the diaphragm) or pelvis within 6 days before registration; however, patients who have received localized radiation therapy to bone parts for bone metastases (e.g., lumbar spine) are not excluded
- Patients taking certain medications within 48 hours before starting treatment
- Patients otherwise deemed inappropriate for participation in this clinical study
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | iihara |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
500-8046
Address
1-1 Yanagido, Gifu
TEL
+81582306000
iihara.hirotoshi.p7@f.gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Iihara |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
500-8046
Address
1-1 Yanagido, Gifu
TEL
0582306000
Homepage URL
iihara.hirotoshi.p7@f.gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu Univerisity
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review committee of the Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu
Tel
+8158-230-6059
rinri@gifu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062756
