UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013333 |
|---|---|
| Receipt number | R000015515 |
| Scientific Title | PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer. |
| Date of disclosure of the study information | 2014/03/04 |
| Last modified on | 2014/03/04 21:41:24 |
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Basic information
Public title
PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.
Acronym
PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.
Scientific Title
PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.
Scientific Title:Acronym
PhaseI/II study of carboplatin plus nab-paclitaxel plus bevacizumab administered to advanced non-squamous non-small cell lung cancer.
Region
| Japan |
Condition
Condition
advanced non-squamous non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the recommended dose of nab-paclitaxel for the chemotherapy of carboplatin plus nab-paclitaxel plus bevacizumab for non-squamous NSCLC, and to evaluate the efficacy and safety of this therapy when administered at recommended dose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
phase I: to determine recommended dose
phaseII: response rate
Key secondary outcomes
phaseII:to evaluate disease control rate, progression free survival, overall survival and safety profile
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
phaseI
Carboplatin and bevacizumab will be administered by fixed dose on day1, and nab-paclitaxel (nab-PTX) at the dose levels as described below.
level 0:
nab-PTX (75mg/m2) day1,8
carboplatin (AUC 6) day1
bevacizumab (15mg/kg) day1
level 1:
nab-PTX (100mg/m2) day1,8
carboplatin (AUC 6) day1
bevacizumab (15mg/kg) day1
level 2:
nab-PTX (100mg/m2) day1,8,15
carboplatin (AUC 6) day1
bevacizumab (15mg/kg) day1
At first three patients will receive the treatment at a starting dose of level1. Nab-PTX dose will be escalated (level 2) or deescalated (level 0) according to standard 3+3 rule. Dose limiting toxicities (DLTs) will be defined as any of the following drug related events occurring in the first cycle: (1)grade 4 neutropenia for 4 and more days; (2)grade 3 or 4 febrile neutropenia; (3)grade 4 thrombocytopenia; (4)grade 3 or 4 non-hematologic toxicity, excluding nausea and vomiting; (5)grade 4 hypertension; (6)skipping of day8 or day15 administration; and (7)not fulfill the criteria for starting second cycle therapy on day22.
phase II
Recommended dose of nab-PTX plus carboplatin and bevacizumab therapy will be administered every three weeks up to 6 cycles. After these therapies, in case of more than stable disease bevacizumab administration will be continued every three weeks.
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 confirmed non-squamous non-small cell lung cancer.
(2)Stage IIIB, out of radical setting radiotherapy/IV,M1a/IV, M1b
(3) ECOG PS 0 or 1
(4)Measurable or nonmeasurable disease as defined by RECIST criteria
(5)No prior chemotherapy
(6)Adequate bone marrow, renal, and hepatic parameters
(7)No history of major hemoptysis
(8)Informed consent
Key exclusion criteria
(1) Hemorrhagic Diathesis, coagulopathy
(2) Presence of cardiovascular invasion
(3) Presence of any tumor with cavitation
(4) Presence of significant interstitial lung disease or lung fibrosis
(5) Uncontrolled intercurrent illness (eg. hypertension, diabetes mellitus, gastro- intestinal fistula, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia)
(6) Ongoing/active infection
(7) Arterial thrombotic events or significant vascular disease
(8) Uncontrolled gastric ulcer
(9) Gastrointestinal perforation within the past 12 months
(10) Prior malignancy
(11) Uncontrolled pleural effusion or ascites
(12) Clinically significant pericardial effusion
(13) Hypersensitivity history for test drugs
(14) Pregnancy or breast-feeding
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Akita |
Organization
Nagoya City West Medical Center
Division name
respiratory medicine
Zip code
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya 462-8508 Japan
TEL
052-991-8121
k.akita.86@west-med.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Akita |
Organization
Nagoya City West Medical Center
Division name
respiratory medicine
Zip code
Address
1-1-1 Hirate-cho, Kita-ku, Nagoya 462-8508 Japan
TEL
052-991-8121
Homepage URL
k.akita.86@west-med.jp
Sponsor or person
Institute
Nagoya City West Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nagoya City West Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya City East Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015515
