UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003102
Receipt No. R000003678
Scientific Title Phase I-II Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for Non-Small Cell Lung Cancer
Date of disclosure of the study information 2010/01/27
Last modified on 2019/02/04

* 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 Phase I-II Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for Non-Small Cell Lung Cancer
Acronym Phase I-II Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for Non-Small Cell Lung Cancer
Scientific Title Phase I-II Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for Non-Small Cell Lung Cancer
Scientific Title:Acronym Phase I-II Study of Irinotecan and Erlotinib in Patients with Erlotinib Failure for Non-Small Cell Lung Cancer
Region
Japan

Condition
Condition Erlotinib Failure for Non-Small Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Estimate of MTD and Deternmination of RD on Phase I
Safety status on Phase II
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes DLT and RD on Phase I
RR on Phase II
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
Medicine
Interventions/Control_1 Ilinotecan and Erlotinib
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 Erlotinib Failure for Non-Small Cell Lung Cancer.
Key exclusion criteria Clinically significant serious disease
Target sample size 43

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nishio
Organization CancernInstitute Hospital
Japanese foundation for cancer reseach
Division name Thoracic Medical Oncology
Zip code
Address 3-8-31 Ariake,Koto-ku,Tokyo,Japan
TEL 03-3520-0111
Email mnishio@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Horiike
Organization CancernInstitute Hospital
Division name Thoracic Medical Oncology
Zip code
Address 3-8-31 Ariake,Koto-ku,Tokyo,Japan
TEL 03-3520-0111
Homepage URL
Email atsushi.horiike@jfcr.or.jp

Sponsor
Institute Department of Thoracic Medical Oncoligy
CancernInstitute Hospital
Japanese foundation for cancer reseach
Institute
Department

Funding Source
Organization Department of Thoracic Medical Oncoligy
CancernInstitute Hospital
Japanese foundation for cancer reseach
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
Address
Tel
Email

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
2010 Year 01 Month 27 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 Terminated
Date of protocol fixation
2009 Year 12 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 01 Month 27 Day
Last modified on
2019 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.