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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010532
Receipt No. R000012315
Scientific 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)
Date of disclosure of the study information 2013/05/01
Last modified on 2016/06/12

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Basic information
Public 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)
Acronym 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)
Scientific 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)
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Sho Saeki
Organization Kumamoto University School
of Medicine
Division name Department of Respiratory Medicine
Zip code
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
1st name
Middle name
Last name Shinya Sakata
Organization Kumamoto University School
Division name Department of Respiratory Medicine
Zip code
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

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)

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
2013 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.lungcancerjournal.info/
Number of participants that the trial has enrolled
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.
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
2013 Year 04 Month 03 Day
Date of IRB
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

Other
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

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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