UMIN-CTR Clinical Trial

Public title

A phase I study of bevacizumab and amrubicin after platinum-based chemotherapy in patients with advanved non-squamous non-small cell lung cancer

Acronym

Phase I study of bevacizumab and amrubicin

Scientific Title

A phase I study of bevacizumab and amrubicin after platinum-based chemotherapy in patients with advanved non-squamous non-small cell lung cancer

Scientific Title:Acronym

Phase I study of bevacizumab and amrubicin

Region

Japan

Condition

Non-Small Cell Lung Cancer
Non-Squamous cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine the maximum tolerated dose (MTD) of amrubicin and bevacizumab for non-squamous non-small cell lung cancer previously treated with platinum-based chemotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Maximum tolerated dose (MTD) of amrubicin and bevacizumab

Key secondary outcomes

Anti tumor efficacy

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Level 1 bevacizumab 15mg/kg and amrubicin (25mg/m2)
Level 2 bevacizumab 15mg/kg and amrubicin (30mg/m2)
Level 3 bevacizumab 15mg/kg and amrubicin (35mg/m2)
Level 4 bevacizumab 15mg/kg and amrubicin (40mg/m2)
Level 5 bevacizumab 15mg/kg and amrubicin (45mg/m2)

If none of the 3 patients who had been originally allocated to a dosage level experienced DLT, the dose of amrubicin was increased to the next level. If one of the 3 patients experienced DLT at that level, 3 additional patients were enrolled for the further evaluation of toxicity. If two of 3 patients DLT at that level, that dose was defined as the MTD.

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

Age-lower limit

Not applicable

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Histology/cytology-proven non-squamous non-small cell lung cancer
2)Stage IIIB, IV and unsuitable for radiotherapy
3)With one or more measurable disease based on RECIST
4)Previously treated with platinum-based chemotherapy as a first line treatment
5)Performance status(ECOG): 0-1
6)Age<75
7)Adequate organ function
8)Written informed consent

Key exclusion criteria

1)Squamous cell carcinoma
2)Discontinued bevacizumab due to its toxicity during a first line treatment
3)Serious infections/with fever
4)Serious clinical problems
5)Interstitial pneumonia/lung fibrosis on chest X-ray
6)History or complication of hemoptysis with 2.5ml per time or more
7)Continuous bloody phlegm more than 1 week or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent.
8)Tumor cavitation
9)Uncontrollable hypertension
10)History of GI perforation
11)Previous treatment with amrubicin
12)Massive pericardial, pleural effusion, ascites
13)Active concomitant malignancy
14)Symptomatic brain metastasis
15)Previous drug allergy
16)Those judged to be not suitable by the attending physician

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Masao Ichiki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Respiratory Medicine

Zip code

Address

1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Masao Ichiki

Organization

National Hospital Organization Kyushu Medical Center

Division name

Department of Respiratory Medicine

Zip code

Address

TEL

092-852-0700

Homepage URL

Email

Institute

National Hospital Organization Kyushu Medical Center
Department of Respiratory Medicine

Institute

Department

Personal name

Organization

National Hospital Organization Kyushu Medical Center
Department of Respiratory Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

06

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

05

Month

23

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

16

Day

Last modified on

2013

Year

06

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009641