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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024551
Receipt No. 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 2018/04/19

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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
Middle name
Last name Junji Uchino
Organization Kyoto prefectural University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5513
Email uchino@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Tanimura
Organization Kyoto prefectural University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5513
Homepage URL
Email keiko-t@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural University of Medicine
Institute
Department

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
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 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
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
2016 Year 11 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 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
2016 Year 10 Month 24 Day
Last modified on
2018 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028254

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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