UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023763 |
|---|---|
| Receipt number | 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 16:11:13 |
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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
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
thonda@med.teikyo-u.ac.jp
Sponsor or person
Institute
Division of Medical Oncology
Department of Internal Medicine Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018461
