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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012788
Receipt No. R000014933
Scientific Title A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin in Chemotherapy-Naive Patients with Advanced Non-Small-Cell Lung Cancer
Date of disclosure of the study information 2014/01/14
Last modified on 2015/05/26

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Basic information
Public title A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin
in Chemotherapy-Naive Patients with
Advanced Non-Small-Cell Lung Cancer
Acronym A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin
in Chemotherapy-Naive Patients with
Advanced Non-Small-Cell Lung Cancer
Scientific Title A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin
in Chemotherapy-Naive Patients with
Advanced Non-Small-Cell Lung Cancer
Scientific Title:Acronym A Phase I Study of Weekly Nab-Paclitaxel/Carboplatin
in Chemotherapy-Naive Patients with
Advanced Non-Small-Cell Lung Cancer
Region
Japan

Condition
Condition previously untreated advanced non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine the recommended dose of chemotherapy with carboplatin plus weekly nab-paclitaxel in patients with previously untreated advanced non-small cell lung cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes determine the recommended dose
Key secondary outcomes Safety, Efficacy

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 weekly for 3 of 4 weeks (3-weekly) with carboplatin on day 1 of each 4-week cycle
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) Cytologically or histologically documented non-small cell carcinoma of the lung.
2)previously untreated recurrence with distant metastasis after surgery, or previously untreated clinical stage IV or IIIB (including only patients with no indications for curative radiotherapy)
3) age older thean 20years at the time of registration
4) Have Eastern Cooperative Oncology Group performance status (PS) of 0 or 1
5) Have measurable lesions (RECIST version1.1)
6) Have adequate organ function within 14 days before study entry
leucocytes >3000/mm3
neutrophils>1,500/mm3
platelets >100,000/mm3
hemoglobin > 9g/dl],
adequate hepatic function
adequate renal function
partial pressure of arterial oxygen>60Torr or Peripheral capillary oxygen saturation>90%
8) Have signed an informed consent document
Key exclusion criteria 1)History of radiotherapy for a primary lesion
2)Superior vena cava syndrome
3)Hisstory of severe drug allergy
4)With massive or uncontrolled pleural effusion
5)With massive or uncontrolled pericardial effusionor ascites
6)With active infection
7)interstitial pneumoia/active lung fibrosis on chest x-ray
8)With symptomatic brain metastasis
9)active concomitant malignancy
10)Uncontrolled psychiatric disease
11)Peripheral sensory or motor neuropathy severe than Grade 2(by CTCAE ver4.0)
12)Others judged by attending physician
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masataka Hirabayashi
Organization Hyogo Prefectural Amagasaki Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-1-1, Higashidaimotsucho, Amagasaki-shi, Hyogo, 660-0828, Japan
TEL 06-6482-1521
Email Masataka_Hirabayashi@pref.hyogo.lg.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Hirano
Organization Hyogo Prefectural Amagasaki Hospital
Division name Department of Respiratory Medicine
Zip code
Address 1-1-1, Higashidaimotsucho, Amagasaki-shi, Hyogo, 660-0828, Japan
TEL 06-6482-1521
Homepage URL
Email khirano1979@gmail.com

Sponsor
Institute Department of Respiratory Medicine in Hyogo Prefectural Amagasaki Hospital
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 兵庫県立尼崎病院

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2013 Year 12 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 14 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 01 Month 08 Day
Last modified on
2015 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014933

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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