UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013390 |
|---|---|
| Receipt number | R000015272 |
| Scientific Title | Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. |
| Date of disclosure of the study information | 2014/03/11 |
| Last modified on | 2016/09/11 11:42:54 |
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Basic information
Public title
Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.
Acronym
Phase II study of weekly nab-PTX in patients with NSCLC previously treated with platinum-based chemotherapy.
Scientific Title
Phase II study of weekly nab-paclitaxel in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.
Scientific Title:Acronym
Phase II study of weekly nab-PTX in patients with NSCLC previously treated with platinum-based chemotherapy.
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of nab-paclitaxel monotherapy in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Overall Survival
Progression Free Survival
Time to Treatment Failure
Disease Control Rate
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 100mg/m2 is administered by an infusion lasting 30 minutes on days 1, 8, 15 every 4weeks.
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 confirmed non-small cell lung cancer
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV or postoperative recurrence
3) Disease progression or recurrence after the last treatment for non-small cell lung cancer is confirmed by radiological image. The number of previous regimens must be 2 or less
*Previous treatments should include at least one platinum-based regimen
*Adjuvant chemotherapy is counted as one regimen if the disease recurred within a year after the completion of postoperative adjuvant chemotherapy, or within a year after surgery in patients given preoperative adjuvant chemotherapy
* The following treatments are not counted as one regimen
1.Picibanil use for pleurosclerosis
2.Continuation maintenance therapy
3.EGFR-TKI and ALK inhibitor use for each driver mutation
4) At least one measurable lesion
5) Age of 20 years or older
6) ECOG Performance status of 0-2
7) Sufficient major organ function as bellow
*Neutrophil count >= 1,500 /mm3
*Platelet count >= 100,000 /mm3
*Hemoglobin >= 9.0 g/dL
*AST <= 100 IU/L
*ALT <= 100 IU/L
*total bilirubin <= 1.5 mg/dL
*PaO2 >= 60 Torr or more (or SpO2 >= 94% or more)
8) Written informed consent
Key exclusion criteria
(1) Previous treatment with paclitaxel
(2) Patients who remain influence of prior treatment which disturb protocol treatment
(3) Symptomatic brain metastasis
4) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion
5) Active infection requiring administration of systemic treatment with antibiotics. e.g. Body temperature rose higher than 38 degree centigrade
6) Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed
interstitial pneumonitis (except documented radiation pneumonitis) or pulmonary fibrosis, poorly-controlled diabetes, cardiac failure, renal failure, liver failure, active gastrointestinal ulceration, myocardial infarction within 6 months, and Grade 3 or higher angina
7) Patients with autoimmune disease requiring treatment with an immunosuppressive agent such as azathiopurine, chlorambucil, cyclophosphamide, ciclosporin, methotrexate, and steroids
8) Active double cancer (synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval), except in situ cervical cancer cured by local treatment, gastric or colon cancer curatively resectable with endoscopy, and resectable non-melanoma skin cancer
9) Confirmed or possible pregnancy, lactation, willingness to become pregnant
(for women), or willingness to have a child (for men)
10) Psychiatric disorder or symptom that makes participation of the patient difficult
11) Continuous administration of a steroid
12) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Fujita |
Organization
National Hospital Organization Asahikawa Medical center
Division name
Respiratory Medicine
Zip code
Address
7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan
TEL
0166-51-3161
yuka@asahikawamc.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Fujita |
Organization
National Hospital Organization Asahikawa Medical center
Division name
Respiratory Medicine
Zip code
Address
7 Hanasaki-cho Asahikawa Hokkaido 070-8644 Japan
TEL
0166-51-3161
Homepage URL
yuka@asahikawamc.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Asahikawa Medical center
Institute
Department
Personal name
Funding Source
Organization
None
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
独立行政法人国立病院機構 旭川医療センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 11 | 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 | 12 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | 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
| 2014 | Year | 03 | Month | 11 | Day |
Last modified on
| 2016 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015272
