UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024551 |
|---|---|
| Receipt number | R000028254 |
| Scientific Title | PhaseII study of the efficacy of DOCETAXEL plus RAMUCIRUMAB for NSCLC with brain metastasis |
| Date of disclosure of the study information | 2016/11/19 |
| Last modified on | 2020/10/27 20:29:36 |
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Basic information
Public title
PhaseII study of the efficacy of DOCETAXEL plus RAMUCIRUMAB for NSCLC with brain metastasis
Acronym
PhaseII study of DOCETAXEL plus RAMUCIRUMAB for NSCLC with brain metastasis
Scientific Title
PhaseII study of the efficacy of DOCETAXEL plus RAMUCIRUMAB for NSCLC with brain metastasis
Scientific Title:Acronym
PhaseII study of DOCETAXEL plus RAMUCIRUMAB for NSCLC with brain metastasis
Region
| Japan |
Condition
Condition
Non-small cell lung carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of ramucirumab plus docetaxel for unresectable advanced or recurrent NSCLC patients with brain metastasis who had progressed after prior chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
intracranial progression free survival
overall survival
disease control rate
overall response rate
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel plus 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. Patients who are histology or cytology confirmed as advanced non-small cell lung cancer.
2. Patients have asymptomatic brain metastasis, at least one measurable lesion in the brain (defined as lesion more than 5mm and a double or more of a slice thickness in longest dimension) confirmed by brain MRI. Stereotactic radiosurgery (SRS) (including Gamma Knife or Cyber Knife) before enrollment is allowed. At least 2 weeks has elapsed from the completion of SRS.
3. Patients who have disease progression during or after first-line chemotherapy (including platinum-based agents, non-platinum-based agents, EGFR-TKI, ALK inhibitor or immune checkpoint inhibitor) with or without maintenance therapy.
- Patients with progressed disease during or after completion of prior therapy for advanced/metastatic disease.
- Prior bevacizumab as first-line and/or maintenance therapy is allowed.
4. Performance Status (ECOG) is 0 or 1 at the time of acquisition of consent.
5. Patients at least 20 years of age (age at the time of acquisition of consent).
6. Patients who have adequate bone marrow, hepatic, and renal functions have all been confirmed as normal within 14 days prior to enrollment.
7. Patients with life expectancy of at least 3 months.
Key exclusion criteria
1. Patients who have never been received anticancer agents.
2. Patients who are currently receiving other anticancer therapy.
3. Patients who have symptomatic brain metastasis or patients who have undergone whole brain radiotherapy or surgical resection for brain metastasis.
4. Patients who have meningeal metastasis.
5. Patients who have either bleeding into the brain metastasis or other CNS hemorrhage on imaging performed within 21days before acquisition of consent.
6. Patients who have radiographic evidence of intratumor cavitation or major blood vessels invasion or encasement by cancer.
7. Patients who have experienced uncontrolled coagulation disorder (acquired or hereditary).
8. Patients who have experienced arterial thromboembolic events, deep vein thrombosis, serious bleeding complications or GI perforation/fistula within 6 months prior to acquisition of consent.
9. Patients who have cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis with history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
10. Patients who have a serious or non-healing wound, ulcer, or bone fracture within 28 days prior to acquisition of consent.
11. Patients who have uncontrolled or poorly-controlled hypertension, metabolic disorder or clinically serious infection.
12. Patients who are pregnant, nursing or possibly pregnant.
13. The patient is receiving chronic antiplatelet therapy.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Junji |
| Middle name | |
| Last name | Uchino |
Organization
Kyoto prefectural University of Medicine
Division name
Department of Respiratory Medicine
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5513
uchino@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Tanimura |
Organization
Kyoto prefectural University of Medicine
Division name
Department of Respiratory Medicine
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5513
Homepage URL
keiko-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan
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
Ethics Committees of Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
0752515111
m-muramatsu76@pref.kyoto.lg.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
京都府立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 19 | 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
25
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
| 2016 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2020 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028254
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