UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010963 |
|---|---|
| Receipt number | R000012832 |
| Scientific Title | Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer. |
| Date of disclosure of the study information | 2013/06/17 |
| Last modified on | 2017/06/17 11:01:56 |
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Basic information
Public title
Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.
Acronym
Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.
Scientific Title
Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.
Scientific Title:Acronym
Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.
Region
| Japan |
Condition
Condition
Squamous cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine MTD and RD of nab-paclitaxel plus Nedaplatin chemotherapy in patients with advanced squamous cell lung cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Finding a decomending dose
Key secondary outcomes
evaluation of safety and response 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
Level 0
nedaplatin : 100mg/m2(day1)+
nab-paclitaxel: 60mg/m2(day1,8,15)
q4weeks
Level 1
nedaplatin : 100mg/m2(day1)+
nab-paclitaxel: 80mg/m2(day1,8,15)
q4weeks
Level 2
nedaplatin : 100mg/m2(day1)+
nab-paclitaxel: 100mg/m2(day1,8,15)
q4weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven squamous cell lung cancer.
2) Clinical stage IIIB, IV or recurrent disease after surgery.
3) No prior chemotherapy.
No adjuvant chemotherapy within 1 years.
4) Age: 20 to 74
5) ECOG performance status of 0 or 1.
6) With at least one or more measurable lesion by RECIST.
7) Adequate organ function.
8) Life expectancy more than 3 months.
9) Written informed consent.
Key exclusion criteria
1) Severe infection.
2) Severe complications.
3) Uncontrollable pleural or pericardial effusion or ascites.
4) Superior vena cava syndrome.
5) Simultaneous or metachronous double cancers.
6) Symptomatic brain metastases.
7) Prior radiotherapy for primary tumor.
8) Radiotherapy other than primary tumor within 2 weeks.
9) A history of serious drug allergy or severe allergic reaction with albumin.
10) Psycologic illness
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriyuki Masuda |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
042-778-8111
igawa@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Igawa |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL
042-778-8111
Homepage URL
igawa@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Department of Respiratory Medicine
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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 14 | Day |
Last modified on
| 2017 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012832
