UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012966 |
|---|---|
| Receipt number | R000015158 |
| Scientific Title | A Phase I/II study of nab-Paclitaxel plus S-1 therapy in previously treated patients with refractory advanced non-small-cell lung cancer |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2016/07/31 15:06:11 |
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Basic information
Public title
A Phase I/II study of nab-Paclitaxel plus S-1 therapy in previously treated patients with refractory advanced non-small-cell lung cancer
Acronym
A Phase I/II study of nab-PTX plus S-1 therapy in previously treated patients with refractory advanced NSCLC
Scientific Title
A Phase I/II study of nab-Paclitaxel plus S-1 therapy in previously treated patients with refractory advanced non-small-cell lung cancer
Scientific Title:Acronym
A Phase I/II study of nab-PTX plus S-1 therapy in previously treated patients with refractory advanced NSCLC
Region
| Japan |
Condition
Condition
Advanced non-small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety and determine the recommended dose of nab-Paclitaxel plus S-1 therapy as a third- or fourth-line therapy in patients with previously treated advanced or recurrent non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I:Recomended dose
Phase II:Disease control rate
Key secondary outcomes
Response rate, Progression free survival, Overall survival, Adverse events
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
nab-Paclitaxel plus S-1therapy as a third- or fourth-line therapy in patients with previously treated advanced or recurrent non-small cell lung cancer
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 or Cytologically documented non-small-cell lung cancer
(2)Stage IIIB without any indications for operation and radiotherapy or Stage IV
(3)Have measuarable lesion by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria.
(4)The lesions included in the radiation site are not measurable.
(5)recurrent or refractory disease
after two or three previous treatment regimens (including one platinum regimen regimen at least)
(6)one regimen as ALK inhibitor or EGFR-TKI monotherapy
(7)Adjuvant chemotherapy, including platinum doublet (but not counted as a regimen for one year after the final treatment) shall be one regimen. UFT is not counted as one regimen.
(8)It is acceptable even if patients received paclitaxel, S-1 or nab-PTX as a pre-treatment. But if they received S-1 as a pre-treatment, they have to take at least one treatment-free TS1.
(9)Must be 20 or more years old at tne time of consent
(10)Have Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS) 0-2
(11)The case can eat.
(12)Have adequate organ function within two weeks before study entry.
(13)Estimate life expectancy of at least 3 months
(14)Have signed an informed consent document
Key exclusion criteria
(1)Presencee of other active malignancy
(2)SVC syndrome
(3)Myocardial infarction, which was developed within six months
(4)Liver chirrosis
(5)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray
(6)Clinically significant drug allergy
(7)With severe infection, gastrointestinal hemorrhage or cardiac diseases
(8)With persistent diarrhea
(9)With with intestinal paralysis or ileus
(10)Diabetes with poor control
(11)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage
(12)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks.
(13)Symptomatic brain metastasis
(14)Peripheral neuropathy of Grade2 or more
(15)Positive serum HBs antigen
(16)Uncontrolled psychiatric diseases
(17)Pregnancy or lactating patients
(18)with a history of hypersensitivity to nab-PTX, S-1, paclitaxel, or albumin
(19)Others
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Depatment of Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511
TEL
06-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumi Nishino |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Depatment of Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511
TEL
06-6972-1181
Homepage URL
nisino-ka@mc.pref.oska.jp
Sponsor or person
Institute
Depatment of Thoracic Oncology
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Depatment of Thoracic Oncology
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | 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
| 2014 | Year | 01 | Month | 26 | Day |
Last modified on
| 2016 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015158
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