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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030142
Receipt No. R000034427
Scientific Title A Phase Ib study of osimertinib with ramucirumab in EGFR mutated lung adenocarcinoma patients. (LY3009806-IIT-01)
Date of disclosure of the study information 2017/11/28
Last modified on 2019/04/24

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Basic information
Public title A Phase Ib study of osimertinib with ramucirumab in EGFR mutated lung adenocarcinoma patients. (LY3009806-IIT-01)
Acronym Phase Ib study of osimertinib with ramucirumab (LY3009806-IIT-01)
Scientific Title A Phase Ib study of osimertinib with ramucirumab in EGFR mutated lung adenocarcinoma patients. (LY3009806-IIT-01)
Scientific Title:Acronym Phase Ib study of osimertinib with ramucirumab (LY3009806-IIT-01)
Region
Japan

Condition
Condition To assess the efficacy and toxicity of Osimertinib plus ramucirumab
Classification by specialty
Pneumology Psychosomatic Internal Medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety, Efficacy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dose limiting toxicity (DLT)
Key secondary outcomes Overall response rate (ORR)
Progression-free survival (PFS)
Overall survival (OS)
Time to treatment failure (TTF)
Safety

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 Osimertinib + ramucirumab
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 confirmed, lung adenocarcinoma, with clinical stage IIIB, IV, or recurrence after curative surgery, or radiotherapy.
2) With EGFR sensitive mutation (exon 19 deletion, or exon 21 L858R)
3) Radiological progression was confirmed after the first or second generation EGFR-TKIs (gefitinib, erlotinib, afatinib, or dacomitinib), and EGFR T790M mutation was detected.
4) Aged more than 20 years at the time of study entry
5)ECOG performance status (PS) of 0-1
6) With measurable lesion
7) Adequate organ function
Key exclusion criteria 1) Any history of interstitial pneumonia, or any evidence of interstitial lung disease by CT scan.
2) Not able to swallow tablets.
3) Considered to be high risk of bleeding.
4) The patient has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of protocol therapy
5) With serious illness or medical condition6) Undergone prior therapy, or procedure within defined period prior to enrollment
7) With local infection that requires procedure, or active systemic infection
8) HBS antigen (+)
9) Leptomeningeal carcinomatosis
10) Concurrent malignancy
11) Pregnant (must be negative serum pregnancy test or repeated urine test within 7 days prior to first dose), breast feeding, childbearing potential at enrollment, or not willing to use adequate contraceptive methods
12) Serious psychiatric condition that is hard to register this study
13) Known history of serious allergy
14) Other reason that the investigator would make the patient ineligible for entry into this study.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Yamamoto
Organization Wakayama Medical University
Division name Respiratory Medicine and Clinical Oncology
Zip code
Address Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL 073-441-0619
Email nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Ozawa
Organization Wakayama Medical University
Division name Respiratory Medicine and Clinical Oncology
Zip code
Address Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL 073-441-0619
Homepage URL
Email nbyamamo@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Eli Lilly and Company
Organization
Division
Category of Funding Organization Profit organization
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 和歌山県立医科大学附属病院(和歌山県)、神戸市立医療センター中央市民病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 28 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
2017 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 28 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
2017 Year 11 Month 28 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034427

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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