UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030142 |
|---|---|
| Receipt number | 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 | 2021/08/12 13:48:04 |
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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 | Nobuyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
Respiratory Medicine and Clinical Oncology
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL
073-441-0619
nbyamamo@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ozawa |
Organization
Wakayama Medical University
Division name
Respiratory Medicine and Clinical Oncology
Zip code
641-8509
Address
Kimiidera 811-1, Wakayama-city, Wakayama, Japan
TEL
073-441-0619
Homepage URL
nbyamamo@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
Wakayama Medical University
Address
811-1, kimiidera
Tel
+81734410619
wa-rinri@wakayama-med.ac.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
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
6
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
| 2017 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2021 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034427
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