UMIN-CTR Clinical Trial

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
Email	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
Email	akinoue@idac.tohoku.ac.jp

Sponsor
Institute	North Japan Lung Cancer Study Group (NJLCG)
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017319