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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023763
Receipt No. R000018461
Scientific Title The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more
Date of disclosure of the study information 2016/08/25
Last modified on 2016/08/25

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Basic information
Public title The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more
Acronym The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more
Scientific Title The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more
Scientific Title:Acronym The Phase II study on the efficacy and safety of weekly nab-paclitaxel with 3 rd line therapy or more of advanced or recurrent non-small cell lung cancer after disease progression on 2nd line therapy or more
Region
Japan

Condition
Condition Advanced or recurrent non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 We consider the efficacy and safety of 3rd or 4th line weekly nab-paclitaxel therapy of advanced or recurrent non-small cell lung cancer with 2 regimen or more chemotherapeutic treatment history.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Disease Control Rate
Key secondary outcomes Response Rate, Overall survival, Progression free survival, Time to Treatment Failure, Adverse events (adverse reactions) occurrence rate

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 weekly nab-Paclitaxel
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.Non-small cell lung cancer with cytological (except sputum cytology) or histologically diagnosis.
2.There is a chemotherapy treatment history of 2 or 3 regimen that includes a platinum doublet therapy and docetaxel single agent therapy. In addition, it does not count as one regimen for EGFR-TKI and ALK inhibitor. However, erlotinib for EGFR gene mutation with wild type to count as 1 regimen. In addition, for patients who relapsed within 6 months from adjuvant chemotherapy last administration day, it counted as one regimen the last dose regimen of adjuvant chemotherapy.
3.It has been passed after 2 weeks or more from radiation therapy.
4.Cases with measurable lesions.
5.Age cases of more than 20 year old
6.ECOG Performance status (PS) 0-2.
7.Major organ function (bone marrow, heart, liver, kidney, etc.) is satisfaction on registrationin date from 14 days.

The number of neutrophils: >= 1,500 /mm3
Hemoglobin value: >= 8.5 g/dL
Platelet count : >= 100,000/mm3
AST value, ALT values: <= 100 IU/L
Total bilirubin: <= 1.5 mg/dL
Serum creatinine values: <= 1.5mg/dL
Cardiac function: No abnormal findings it becomes clinical problem
Peripheral neuropathy: <= Grade1
Respiratory function: SpO2: 90% or more
8.Patients can be expected survival from three months or more after treatment started.
9.Patient has agreed for participation in this study in writing.
Key exclusion criteria 1.Patients with paclitaxel treatment history.
2.Patients with hypersensitivity to paclitaxel or preparations containing albumin.
3.Patients with active double cancer in need of treatment. However it is not excluded that carcinoma in situ that is judged to be healing by local treatment, intramucosal cancer equivalent of lesions or other cancers unlikely in need of treatment.
4.The infection requiring systemic treatment (including patient of HBs antigen-positive).
5.Serious complications (heart disease, interstitial pneumonia, uncontrolled high blood pressure or diabetes, etc.)
6.there is a possibility of pregnancy or during pregnancy or lactating women.
7.Patients with psychosis or psychotic symptoms is determined to be difficult to participants in a clinical trial.
8.Patients during systemic administration steroids therapy(oral or intravenous).
9.Patients with symptomatic brain metastases.
10.Other, cases physicians it is judged unsuitable for registration of this clinical trial.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Seki
Organization Department of Internal Medicine
Teikyo University School of Medicine
Division name Division of Medical Oncology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL +81-3-3964-1211
Email nseki@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Honda
Organization Department of Internal Medicine Teikyo University School of Medicine
Division name Division of Medical Oncology
Zip code
Address 2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL +81-3-3964-1211
Homepage URL
Email thonda@med.teikyo-u.ac.jp

Sponsor
Institute Division of Medical Oncology
Department of Internal Medicine Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Division of Medical Oncology
Department of Internal Medicine Teikyo University School of 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
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 帝京大学医学部内科学講座 腫瘍内科

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 25 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 Enrolling by invitation
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 01 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2019 Year 07 Month 31 Day
Date trial data considered complete
2019 Year 07 Month 31 Day
Date analysis concluded
2019 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 25 Day
Last modified on
2016 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018461

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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