UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027223 |
|---|---|
| Receipt number | R000031172 |
| Scientific Title | A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2018/12/27 09:21:01 |
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Basic information
Public title
A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Acronym
A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Scientific Title
A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Scientific Title:Acronym
A phase II study of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of docetaxel plus ramcirumab with pegfilgrastim in treated patients with advanced non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of febrile neutropenia during all cycles of ramucirumab plus docetaxel therapy
Key secondary outcomes
Response rate
Overall survival
Progression free survival
Adverse events
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
Add pegfilgrastim to docetaxel plus ramcirumab treatment as primary prophylaxis
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)Histologically and/or cytologically proven non-small cell lung cancer
2)Previously treated non-small cell lung cancer, with stage III of unsuitable for radiotherapy, stage IV and recurrent disease
3)Patients who have treated with at least one cytotoxic chemotherapy
(In patients with driver mutations such as EGFR mutation or ALK rearrangement, tyrosine kinase inhibitor treatement is required before enrolling this study.)
4)Have measurable lesion
5)Must be 20 or more years old at the time of consent
6)Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
7)Have adequate organ function within two week before study entry
8)Estimated life expectancy of at least 12 weeks
9)Have signed an informed consent document
Key exclusion criteria
1)Interstitial pneumonia , fibroid lung confirmed by CT.
2)History of serious drug allergy
3)Patient with much ascetic fluid, pleural effusion, cardiac effusion.
4)Obvious tumor invasion to main thoracic vessel
5)Have lung cavity
6)Histoly of hemoptysis within two months
7)History of thoracic radiation therapy
8)Tumor invasion to central airway
9)Uncontrolled coagulation disorder or receiving anticoagulant drugs
10)Have inflammatory bowel disease
11)History of thrombosis
12)Have active wounds
13)Uncontrollable hypertension
14)Proteinuria
15)Patient with active infection
16)Symptomatic brain metastases
17)Patient with active double cancers
18)Have active severe heart diseases
19)Patient with impaired mental status
20)Pregnancy
21)Other ineligible status judged by attending doctor
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya Kawaguchi |
Organization
Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL
06-6645-3793
kawaguchi.tomoya@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Sawa |
Organization
Osaka City University
Division name
Department of Respiratory Medicine
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka, 545-8585, Japan
TEL
06-6645-3793
Homepage URL
sawa.kenji@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
Department of Respiratory Medicine
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
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
大阪市立大学医学部附属病院（大阪府）
ベルランド総合病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 08 | 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
| 2017 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | 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 | 05 | Month | 02 | Day |
Last modified on
| 2018 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031172
