UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038644
Receipt number R000042017
Scientific Title A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for highly emetogenic chemotherapy in breast cancer.
Date of disclosure of the study information 2019/11/20
Last modified on 2022/01/06 10:12:12

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Basic information

Public title

A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for highly emetogenic chemotherapy in breast cancer.

Acronym

PATROL-II

Scientific Title

A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for highly emetogenic chemotherapy in breast cancer.

Scientific Title:Acronym

PATROL-II

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Hematology and clinical oncology Not applicable

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Efficacy of antiemetic therapy with a combination of palonosetron (PALO), aprepitant (APR), and olanzapine (OLN) without steroids for patients with malignancies scheduled to receive initial treatment with highly emetogenic chemotherapy for breast cancer and safety in the phase II trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Total Control in overall phase

Key secondary outcomes

1 TC ratio in acute and late phase
2 Complete response of all period and acute phase, late phase
3 Complete control of all periods and acute and late stages
4 No nausea for all period and acute phase, late phase
5 Time to treatment failure (TTF)
6 adverse events


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 breast cancer
2) Patients who are over 20 years old at thetime of registration
3) The patients whom highly emetogenic chemotherapy for breast cancer is given in for the first time
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) Pregnant, breastfeeding or expecting women or who do not wish to use contraception
12) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) 6.5 or more,
or HbA1c (NGSP) in less than 28 days before registration is the patient with (in the case of JDS more than 6.1%) 6.5% or more.
13) Patients with smoking habit
14) The patients who have difficulty in operation such as the input, and the like of EDC.
15) Patients who are judged to be inappropriate for the study by the investigator

Target sample size

89


Research contact person

Name of lead principal investigator

1st name Toshihiro
Middle name
Last name Hama

Organization

Japanese Foundation for Cancer Reseach
Cancer Institute Hospital

Division name

Department of Pharmacy

Zip code

135-8550

Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan

TEL

03-3520-0111

Email

toshihiro.hama@jfcr.or.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Suzuki

Organization

Hoshi University

Division name

Division of Applied Pharmaceutical

Zip code

142-8501

Address

Ebara 2-4-41, Shinagawa-ku, Tokyo 142-8501, Japan

TEL

03-5498-6241

Homepage URL


Email

kenichi-suzuki@hoshi.ac.jp


Sponsor or person

Institute

Hoshi University
Division of Applied Pharmaceutical

Institute

Department

Personal name



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

Japanese Foundation for Cancer Reseach Cancer Institute Hospital

Address

3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan

Tel

03-3520-0111

Email

med.shinsa@jfcr.or.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 11 Month 20 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

2019 Year 05 Month 01 Day

Date of IRB

2019 Year 10 Month 16 Day

Anticipated trial start date

2019 Year 12 Month 10 Day

Last follow-up date

2022 Year 06 Month 30 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 11 Month 20 Day

Last modified on

2022 Year 01 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042017


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name