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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016735
Receipt No. R000018953
Scientific Title Phase 1/2 study of combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for advanced non-squamous non-small cell lung cancer
Date of disclosure of the study information 2015/03/08
Last modified on 2015/03/08

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Basic information
Public title Phase 1/2 study of combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for advanced non-squamous non-small cell lung cancer
Acronym Phase 1/2 study of combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for advanced non-squamous non-small cell lung cancer
Scientific Title Phase 1/2 study of combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for advanced non-squamous non-small cell lung cancer
Scientific Title:Acronym Phase 1/2 study of combination chemotherapy with Carboplatin, nab-Paclitaxel, and Bevacizumab for advanced non-squamous non-small cell lung cancer
Region
Japan

Condition
Condition Non-squamous 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 Carboplatin+nab-paclitaxel+Bevacizumab combination chemotherapy and to evalutate the efficacy and safety with recommended dose
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes PhaseI Recommended Dose
PhaseII Response Rate
Key secondary outcomes DCR, PFS, OS, Safety

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 Patients receive paclitaxelon days 1,8,15
and Carboplatin(AUC6) on day1 and Bevacizumab (15mg/kg) on day1, every four weeks, up to six cycles. Patients who still control disease without unacceptable toxicity, then continuously treated with Bevacizumab(15mg/kg)on Day1, every three weeks, until disease progression.


nabpaclitaxel+bevacizumab
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically determined non small cell lung cancer
2) Unresectable or StageIIIB or IV without any indications for radiotherapy
3) Have measurable lesions by RECIST
4) No prior chemotherapy
5) Aged 20 to 74 years old
6) ECOG perfornmance status 0 or 1
7)8) adequate organ function
9)Patients are excepted to live at least 3 months
10) Written informed consent




Key exclusion criteria 1) Squamous cell lung cancer
2) History of Severe drug allergies.
3) Double malignancies within 5 years
4) Uncontrolled ascites, pleural effusion or cardiac effusion
5) Current history of hemoptysis
6-7) High risk of bleeding or thrombus events
8) Evidence of bleeding diathesis or coagulopathy
9) Current or previous history of Pericardial effusion
10) Superior vena cava syndrome
11) Spinal cord compression
12) Current or previous (within the last 1 year) history of cerebrovascular disease
13) Traumatic fracture of unrecovery
14) History of active infection
15) Scheduled operation
16) Antithrombotic agent
17) Uncontrollable Gastrointestinal ulceration
18) Current or previous (within the last 1 year)history of GI
perforation
19) Uncontrollable hypertension
20) Severe cardiac disease
21) Interstitial pneumonia or pulmonary fibrosis detectable on X ray
22) With grade2 or more neuropathy
23) Treatment history of bevacizumab
24) Pregnancy, breastfeeding or suspected of being pregnant
25) HBs positive patient
26) Others judged by attending physician
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Souichi Kitaguchi
Organization Hiroshima Asa City Hospital
Division name Medical oncology/Respiratory medicine
Zip code
Address 2-1-1 ,Kabeminami Asakita-ku , Hiroshima,Japan
TEL 082-815-5211
Email s-kitaguchi@asa-hosp.city.hiroshima.jp

Public contact
Name of contact person
1st name
Middle name
Last name Souichi Kitaguchi
Organization Hiroshima Asa City Hospital
Division name Medical oncology/Respiratory medicine
Zip code
Address 2-1-1 ,Kabeminami Asakita-ku , Hiroshima,Japan
TEL 082-815-5211
Homepage URL
Email s-kitaguchi@asa-hosp.city.hiroshima.jp

Sponsor
Institute Hiroshima Asa City 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 広島市立安佐市民病院

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2014 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 Day
Last follow-up date
2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 08 Day
Last modified on
2015 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018953

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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