UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036489
Receipt No. R000040472
Scientific Title A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regimen
Date of disclosure of the study information 2019/04/15
Last modified on 2019/08/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regimen
Acronym PATROL-1
Scientific Title A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regimen
Scientific Title:Acronym PATROL-1
Region
Japan

Condition
Condition malignant tumor(only solid tumor)
Classification by specialty
Gastroenterology Pneumology Hematology and clinical oncology
Adult
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety of the triplet antiemetic therapy with palonosetron, aprepitant, and olanzapine for preventing cisplatin-induced nausea and vomiting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total Control (no vomiting/retching, no rescue medication, and no nausea) proportion within 120 hours after the initiation of cisplatin administration
Key secondary outcomes 1. TC proportion during acute phase (0-24 h) and delayed phase (24-120 h)
2. Complete response (CR: no vomiting/retching, no rescue medication) proportion for the overall phase, the acute phase and the delayed phase
3. Complete control (CC: no vomiting/retching, no rescue medication, and no more than mild nausea) proportion for the overall phase, the acute phase and the delayed phase
4. The proportion of "no nausea" for the overall phase, the acute phase and the delayed phase
5. Time to treatment failure
6. Adverse events
7. Relationship between antiemetic efficacy and pharmacogenomic biomarkers (Exploratory analysis)

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
Medicine
Interventions/Control_1 Palonosetron + Aprepitant + Olanzapine (5 mg)
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 1) Patients with malignant tumor except for hematopoietic malignancy
2) Patients who are over 20 years old at thetime of registration
3) Cisplatin-naive solid malignant tumor patients who will receive cisplatin (>=50 mg/m2)-based chemotherapy
4) Eastern Cooperative Oncology Group(ECOG) performance status(PS) of 0, 1 or 2
5) Patients who have adequate organ functions
<Each of the following values are examined within 2 weeks before registration for this study>
ALT < 100 U/L
AST < 100 U/L
T-Bil < 2.0 mg/dL
CCr >= 55 mL/min
6) Patients who got written informed consent prior to registration
Key exclusion criteria 1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds.
2) Patients taking systemic corticosteroid (oral and intravenous) except for
inhaled or topical corticosteroid preparation
3) Patients having a clear vomiting symptom such as brain metastasis or gastrointestinal obstruction to the passage of foods
4) Patients with symptomatic ascites or pleural effusions requiring therapeutic puncture
5) Patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc.
6) Patients who have convulsive disorders requiring anticonvulsants therapy
7) Patients receieving adrenaline or pimozide
8) Patients who start taking opioids within 48 h prior to registration
9) Patients who received radiation therapy to abdomen or pelvis within 6 days prior to registration or will receive radiation therapy until 6 days after cisplatin administration
10) Patients regularly taking antiemetics other than study drugs
11) Patients who cannot be hospitalized after administration of cisplatin during 6 days
12) Pregnant, breastfeeding or expecting women or who do not wish to use contraception
13) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1 within 28 days before registration
14) Patients with smoking habit
15) Patients who are judged to be inappropriate for the study by the investigator
Target sample size 85

Research contact person
Name of lead principal investigator
1st name Masaya
Middle name
Last name WATANABE
Organization Shizuoka General Hospital
Division name Department of Gastroenterological Surgery
Zip code 420-8527
Address 4-27-1 Kita Ando Aoi-ku, Shizuoka City, 420-8527, Japan.
TEL 054-247-6111
Email masaya-watanabe@i.shizuoka-pho.jp

Public contact
Name of contact person
1st name Daiki
Middle name
Last name TSUJI
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences, Department of Clinical Pharmacology & Genetics
Zip code 422-8526
Address 52-1, Yada, Suruga-ku, Shizuoka, 422-8526, JAPAN
TEL 054-264-5674
Homepage URL
Email d-tsuji@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka, School of Pharmaceutical Sciences
Institute
Department

Funding Source
Organization University of Shizuoka, School of Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Shizuoka
Address 52-1, Yada, Suruga-ku, Shizuoka, 422-8526, JAPAN
Tel 054-264-5102
Email tyous10@u-shizuoka-ken.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
2019 Year 04 Month 15 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
2018 Year 12 Month 28 Day
Date of IRB
2019 Year 04 Month 02 Day
Anticipated trial start date
2019 Year 04 Month 23 Day
Last follow-up date
2021 Year 04 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 12 Day
Last modified on
2019 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040472

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.