UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of combination chemotherapy with nab-paclitaxel and Nedaplatin as first-line treatment in patients with advanced squamous cell lung cancer.
Title of the study (Brief title)	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	Noriyuki Masuda
Organization	Kitasato University School of Medicine
Division name	Department of Respiratory Medicine
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL	042-778-8111
Email	igawa@kitasato-u.ac.jp

Public contact
Name of contact person	Satoshi Igawa
Organization	Kitasato University School of Medicine
Division name	Department of Respiratory Medicine
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0374, Japan
TEL	042-778-8111
Homepage URL
Email	igawa@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine Department of Respiratory Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012832