UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016735 |
|---|---|
| Receipt number | 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 02:23:56 |
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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
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
s-kitaguchi@asa-hosp.city.hiroshima.jp
Sponsor or person
Institute
Hiroshima Asa City 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018953
