UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014893 |
|---|---|
| Receipt number | R000017319 |
| Scientific Title | Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer (NJLCG1402) |
| Date of disclosure of the study information | 2014/08/19 |
| Last modified on | 2019/08/03 15:40:21 |
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Basic information
Public title
Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer (NJLCG1402)
Acronym
Biweekly nab-PTX for pretreated NSCLC patients (NJLCG1402)
Scientific Title
Phase I/II study of biweekly nab-paclitaxel in patients with platinum-pretreated non-small cell lung cancer (NJLCG1402)
Scientific Title:Acronym
Biweekly nab-PTX for pretreated NSCLC patients (NJLCG1402)
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the phase I part, to evaluate the maximum tolerated dose of biweekly nab-paclitaxel treatment, and to determine the recommended dose in patients with platinum-pretreated non-small cell lung cancer.
In the phase II part, to evaluate the efficacy and safety with the recommended dose in phase I part.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Determination of the maximum tolerated dose and recommended dose (Phase I)
Response Rate (Phase II)
Key secondary outcomes
Overall Survival
Progression-free Survival
Adverse Events
Disease Control 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
Nab-paclitaxel 100 mg/m2(Level 1) is administered intravenously over 30 minutes on days 1 and 15, repeated every 4weeks. Treatment dose level are level 0 (75mg/m2), level 2(125mg/m2), level 3 (150mg/m2) (Phase I part).
Nab-paclitaxel at the recommended dose is administered intravenously over 30 minutes on days 1 and 15, repeated every 4weeks(Phase II part).
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) Between two and four regimens containing a platinum based chemotherapy are pretreated
-Adjuvant chemotherapy is counted as one regimen if the disease recurred within 1 year after the compretion of postoperative adjuvant chemotherapy, or within 1 year after surgery in patients given preoperative adjuvant chemotherapy.
-EGFR-TKI and ALK inhibitor use for each driver mutation is counted as one regimen.
-Picibanil use for plural effusion is permitted.
-Continuation maintenance therapy is permitted
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
*total bilirubin <= 1.5 mg/dL
*AST <= 100 IU/L
*ALT <= 100 IU/L
*Serum creatinine <= 1.5 mg/dL
*PaO2 >= 60 Torr (or SpO2 >= 93% )
8) Life expectancy of at least 3 months
9) Written informed consent
Key exclusion criteria
1) Previous treatment with paclitaxel
2) Grade 2 or higher peripheral neuropathy
3) Active double cancer
4) Symptomatic brain metastases
5) Pleural and peritoneal effusion likely to require surgical intervention, or pericardial effusion
6) Active infectious disease
7) Severe concurrent disease (intestinal paralysis, intestinal obstraction, poorly controlled diabetes, heart failure, renal failure, hepatic failure, active gastrointestinal ulceration, cardiac infarction within 6 months before enrollment, and grade 3 or higher angina so on)
8) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis.
9) Patient with autoimmune disease requiring immunosuppressive drugs
10) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy.
11) Uncontrolled psychiatric disease
12) Patient are treated with steroid continuously
13) History of severe drug allergies.
14) Physician concludes that the patient's participation in this trial is inappropriate.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Inoue |
Organization
Tohoku University Graduate School of Medicine
Division name
department of Palliative Medicine
Zip code
Address
1-2, Seiryomachi, Aobaku, Sendai
TEL
022-717-7366
akira.inoue.b2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eisaku Miyauchi |
Organization
Tohoku University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-1, Seiryomachi, Aobaku, Sendai
TEL
022-717-8539
Homepage URL
akinoue@idac.tohoku.ac.jp
Sponsor or person
Institute
North Japan Lung Cancer Study Group (NJLCG)
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 19 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017319
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