UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025972 |
|---|---|
| Receipt number | R000029855 |
| Scientific Title | Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2019/08/06 11:23:34 |
* 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 II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Acronym
Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Scientific Title
Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Scientific Title:Acronym
Phase II study of ramucirumab plus docetaxel plus pegfilgrastim with stage IV non-small cell lung cancer patients
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of ramucirumab plus docetaxel plus pegfilgrastim in stage IV 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
Key secondary outcomes
Progression free survival
Overall Response Rate
Disease Control Rate
Overall Survival
Safety, Toxicity
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
Addition of primary prophylaxis with pegfilgrastim to ramcirumab plus docetaxel treatment
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.Patients who have previously treated with chemotherapy and have unresectable clinical stage IV or post-operative recurrence
3.Progression was observed during or after chemotherapy
4. More than twenty years old at the time of the agreement acquisition
5.ECOG Performace Status (PS) 0-1
6.Meets the following criteria
absolute neutrophil: >=1500/mm3
platelet count: >=100,000/mm3
hemoglobin: >=10.0 g/dL
AST and ALT: <=2.5 X ULN
total bilirubin: <=ULN
PT-INR: <=1.5
APTT: <=1.5 X ULN
protein urea: <=1+
7.Written informed consent to participate in this study
Key exclusion criteria
1. Symptomatic brain metastases
2. History of bleeding
3. Patient with HIV or HBV or HCV infection
4. Patient with active infection
5. Fever over 38
6. Patient with serious disease condition (severe heart disease, interstitial pneumonia, uncontrollable hypertension, diabetes mellitus, etc)
6. Severe complication (congestive heart failure, arrhythmia, uncontrollable hyper tension, uncontrollable diabetes)
7.Interstitial pneumonia , fibroid lung confirmed by CT.
8.Patient with much ascetic fluid, pleural effusion, cardiac effusion.
9. Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ)
10. History of severe drug allergy
11.Patient with gastrointestinal perforation within 1 year.
12. Receiving anticoagulant therapy. (Aspirin 325mg or less to allow)
13. Patient thought as of high risk of bleeding (Obvious tumor invasion to main thoracic vessel and cavity) and of thromboembolizm.
14. History of docetaxel or ramcirumab treatment.
15. Considered as unfit to study drug administration by attending doctor according to clinical symptoms or laboratory abnormalities.
16. Considered to be interfere to the agreement or understanding the protocol by attening doctor.
17. Patient with impaired mental status.
18. Pregnancy
19. Other ineligible status judged by attending doctor.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Norimitsu |
| Middle name | |
| Last name | Kasahara |
Organization
Gunma University
Division name
Department of Allergy and Respiratory Medicine
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi, Gunma
TEL
027-220-7111
m14702016@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Norimitsu |
| Middle name | |
| Last name | Kasahara |
Organization
Gunma University
Division name
Department of Allergy and Respiratory Medicine
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi, Gunma
TEL
027-220-7111
Homepage URL
m14702016@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
Gunma Institutional Review Board
Address
3-39-15, Showa-machi, Maebashi, Gunma
Tel
027-220-7111
m14702016@gunma-u.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 10 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029855
