UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)
Title of the study (Brief title)	Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To explore efficacy and safety of weekly nab-paclitaxel therapy for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Objective response rate
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 on day 1,8,15 Cycles are repeated every three weeks.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically or cytologically confirmed diagnosis of NSCLC. 2) Non-small cell lung cancer with stage IIIB,stageIV 3) Age of 20 years or older 4) Performance Status (ECOG) 0-2 5) Tumor has the evaluable lesion. 6) Patient previously treated with platinum-based chemotherapy .and who including EGFR-TKI, ALK inhibitor or maintenance chemotherapy but excluding switch maintenance. *Recurrence within a year or less from the day adjuvant chemotherapy finished is considered a previous treatment. 7) Have adequate organ function within two week before study entry a.Granulocyte count 1,500/mm3 or over b.Platelet count 100,000/mm3 or over c.Hb 9.0 g/dl or over d.AST (GOT) 2.5 x the Upper Limits of Normal (ULN) or under e.ALT (GPT) 2.5 x the Upper Limits of Normal (ULN) or under f.Total bilirubin 1.5 mg/dL or under g.Serum creatinine 1.5 mg/dl or under h.PaO2 60torr or over or SpO2 90% or over 8) Written informed consent to participate.
Key exclusion criteria	1) Anamnesis of hypersensitivity to paclitaxel or albumin 2) Treatment history of taxanes (recurrence after more than one year from adjuvant chemotherapy including taxanes is permitted.) 3) Patient received chemotherapy within 4 weeks or EGFR-TKI within 2 weeks. 4) Patient received curative radiotherapy within 6 weeks or regional palliative radiotherapy within 2weeks. 5) Patient received operation within 4 weeks or surgical open within 2 weeks. 6) Symptomatic brain metastasis 7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment. 8) Active infectious disease in need of systemic administration of anti-bacterial drugs 9) Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on) 10) Patient needed to be administered with immunosuppressive drugs such as azathioprine , cyclophosphamide , methotrexate , or steroid 11) Active double cancer within 5 years of disease free interval (but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer ,by endoscopic mucosal resection , curative cutaneous cancer except for malignant melanoma ) 12) Peripheral neuropathy Grade2 or over 13) Pregnancy or lactating patients , or no intention to practice birth control. 14) Uncontrolled psychiatric disease 15) Physician judged improper to entry this trial
Target sample size	41

Research contact person
Name of lead principal investigator	Sho Saeki
Organization	Kumamoto University School of Medicine
Division name	Department of Respiratory Medicine
Address	1-1-1 Honjo,chuo-ku ,Kumamoto
TEL	096-373-5012
Email	saeshow@wg7.so-net.ne.jp

Public contact
Name of contact person	Shinya Sakata
Organization	Kumamoto University School
Division name	Department of Respiratory Medicine
Address	1-1-1 Honjo, chuo-ku ,Kumamoto
TEL	096-373-5012
Homepage URL
Email	sakata-1027@hotmail.co.jp

Sponsor
Institute	Department of Respiratory Medicine , Kumamoto University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	no
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 03 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.lungcancerjournal.info/
Results	Lung Cancer 2016, in press Results: Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7 % (90% confidence interval, 19.3% to 44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4 to 7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0 to 18.0 months) months. The median number of treatment cycles was four (range, 1 to 17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%. Conclusion: Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.
Other related information

Management information
Registered date	2013 Year 04 Month 18 Day
Last modified on	2016 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012315