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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013390
Receipt No. 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

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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
Email 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
Email yuka@asahikawamc.hosp.go.jp

Sponsor
Institute National Hospital Organization Asahikawa Medical center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015272

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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