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

Email

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


Email

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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name