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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004296
Receipt No. R000005134
Scientific Title A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Date of disclosure of the study information 2010/10/01
Last modified on 2012/10/17

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Basic information
Public title A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Acronym A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Scientific Title A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Scientific Title:Acronym A phase II trial of gefitinib in combination with bevacizumab as first line therapy for advanced non-small-cell lung cancer with mutated EGFR
Region
Japan

Condition
Condition non-small-cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of the combination chemotherapy (gefitinib and bevacizumab) in advanced non-small cell lung cancer with mutated EGFR
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PFS
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 gefitinib, bevacizumab
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. pathologically proven non-squamous non-small cell lung cancer
2. harboring active EGFR mutation other than exon 20 T790M
3. stage IV or ineligibility as candidates for curative treatment
4. measurable tumor sites
5. no prior chemotherapy
no prior systemic anticancer therapy
6. ECOG PS of 0 to 1
7. appropriate organ function
8. expected to live for more than 3 months
9. acquisition of written informed consent
Key exclusion criteria 1. symptomatic brain metastasis
2. pts with hemoptysis with 2.5mL or more
3. pts with radiological findings of tumor invasion to major vessels (i.e. aorta) and cavity lesion
4. pts with bleeding tendency
pts who need continuous use of antithrombotic agents
5. candidate for curative radiation therapy
6. have a history of severe drug allergy
7. woman who is pregnant or wishing to become pregnant
8. pts with massive pleural and cardiac effusion and ascites that need to be immediately treated
9. pts with active co-morbidities including severe conditions of heart diseases, infections, uncontrollable diabetes, uncontollable hypertension, interstitial pneumonia, active hepatitis and thrombotic disease.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuyuki Kiura
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1, Shikatacho, Okayama, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 2-5-1, Shikatacho, Okayama, Japan
TEL
Homepage URL
Email

Sponsor
Institute Okayama Lung Cancer Study Group
Institute
Department

Funding Source
Organization None
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 10 Month 01 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 Completed
Date of protocol fixation
2010 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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 09 Month 29 Day
Last modified on
2012 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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