UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009414
Receipt number R000011061
Scientific Title Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib in NSCLC patients
Date of disclosure of the study information 2012/12/01
Last modified on 2020/01/04 18:28:36

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Basic information

Public title

Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib in NSCLC patients

Acronym

Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib

Scientific Title

Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib in NSCLC patients

Scientific Title:Acronym

Effect of complete fasting and two hours after meal on the pharmacokinetics of Erlotinib

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate the pharmacokinetic difference of erlotinib between the administration on complete fasting and two hours after meal

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

AUC of erlotinib between the administration on complete fasting and two hours after meal

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Cohort A:Period 1, administration on two hours after meal; Period 2, on complete fasting.

Interventions/Control_2

Cohort B: Period 1, administration on complete fasting ;Period 2, on two hours after meal.

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 histologically or cytologically diagnosed NSCLC
2)Advanced or metastatic NSCLC
3)Patients aged >20 years
4)PS(ECOG) of 0 to 2
5)Patients planned to undergo erlotinib therapy as clinical practice
6)Patients who have recovered from the toxicities of any pior treatment
7)Having adequate organ function
8)Written informed consent

Key exclusion criteria

1)Active primary multiple cancer
2)serious concomitant disorders, including an active infection, active gastrointestinal bleeding, or ileus.
3)History of pulmonary fibrosis or interstitial lung disease
5)Patients who required other chemotherapy, rediotherapy, or immuno therapy
6)Patients who qre actively receiving warfarin, PPI, H2-blocker, or inducer or inhibitor of CYP3A4
7)Current smoker
13)Patients with hepatitis B or C virus or human immunodeficiency virus infection
8)pregnancy or lactation

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Tomohide
Middle name
Last name Tamura

Organization

National Cancer Center Hospital

Division name

Division of Internal Medicine and Thoracic Oncology

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN

TEL

0335422511

Email

fu_ji_@yahoo.co.jp


Public contact

Name of contact person

1st name Yutaka
Middle name
Last name Fujiwara

Organization

National Cancer Center Hospital

Division name

Division of Internal Medicine and Thoracic Oncology

Zip code

104-0045

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN

TEL

0335422511

Homepage URL


Email

fu_ji_@yahoo.co.jp


Sponsor or person

Institute

Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

Cancer Fundation

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Cancer Center Hospital

Address

Tsukiji 5-1-1, Chuo-ku, Tokyo, 104-0045, JAPAN

Tel

03-3542-2511

Email

yutakafu@ncc.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

2012 Year 12 Month 01 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007%2Fs00280-015-2778-8

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs00280-015-2778-8

Number of participants that the trial has enrolled

23

Results

AUC and C max in the 2h post-meal status were significantly higher than in the complete fasting status (GMR=1.33, P<0.001; GMR=1.44, P<0.001, respectively). However, because the concentration of erlotinib did not reach the steady state within 7 days in the complete fasting state, we conducted analyses only on day 14, which showed no significant difference in AUC or C max between the two conditions.

Results date posted

2020 Year 01 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients were planned to receive erlotinib therapy as part of their clinical treatment.

Participant flow

Patients were randomly assigned into two cohorts using static block randomization. In cohort A, patients first received erlotinib 2 h after breakfast on days 1 to 7 and then 1 h before breakfast on days 8 to 14. In cohort B, patients received erlotinib 1 h before breakfast on days 1 to 7 and then 2 h after breakfast on days 8 to 14.

Adverse events

In cohort A, a skin rash appeared in 50% of patients within 8 days and in 83% within 15 days. In cohort B, a skin rash was seen in 64% of patients within 8 days and in 82% within 15 days.

Outcome measures

PK analysis and toxicity

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 11 Month 22 Day

Date of IRB

2012 Year 11 Month 22 Day

Anticipated trial start date

2012 Year 12 Month 07 Day

Last follow-up date

2014 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 11 Month 27 Day

Last modified on

2020 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011061


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name