UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012788 |
|---|---|
| Receipt number | 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 14:24:41 |
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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
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
khirano1979@gmail.com
Sponsor or person
Institute
Department of Respiratory Medicine in Hyogo Prefectural Amagasaki Hospital
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014933
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
