UMIN-CTR Clinical Trial

Public title

Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer

Acronym

Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer

Scientific Title

Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer

Scientific Title:Acronym

Phase ll trial of Amrubicin in Patients with Priviously Treated Advanced Non-Small Cell Lung Cancer

Region

Japan

Condition

Lung Squamous Cell Carcinoma

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the efficacy and safety of Amrubicin in patients with previously treated Squamous Cell Lung Cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Disease Control Rate (DCR)

Key secondary outcomes

Overall survival (OS)
Progression-free survival (PFS)
Response Rate (RR)
Toxicity profiles

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

Amrubicin is administered intravenously at a dose of 35 mg/m2/day on days 1-3 every 3 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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically proven squamous cell lung cancer.
2) Stage III/IV without indication for curative resection and post-operative recurrent disease
3) Patients who have previously treated with plutimun doublet chemotherapy.
4) Target lesion is measurable(RECISTver1.1)
5) More than 28 days after last chemotherapy and more than 28 days rest period after radiation
6) ECOG performance status 0-1
7) Patients aged 20-74 years
8) Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment:
Leukocyte counts, 4,000/mm3 to 12,000/mm3.
Neutrophil counts, 2,000/mm3 or over.
Platelets, 100,000/mm3 or over.
Hemoglobin, 9.5g/dL or over
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Serum bilirubin, 1.5mg/dl or less.
Serum creatinin, x 1.5 of ULN or less.
Arterial oxygen partial pressure 60 Torr or above.
Adequate heart function by ECG.
LVEF, 60% or over.
9) Written informed consent from the patients

Key exclusion criteria

1) Patients who have previously treated with chemotherapy containing amrubicin.
2) Patients with symptomatic brain metastasis.
3) Patients with massive uncontrolled pleural or pericardial effusion ,or ascites.
4) Patients with active severe infections
5) Patients with double cancer within 5 years.
6) Patients with active interstitial pneumonia recognized by chest X-ray.
7) Patients with serious drug allergic reactions.
8) Patients with active concomitant pregnancy.
9) Patients with cardiac infarction or
unstable angina within 12 months.
Patients need to recieve medications for their bad heart function.
10) Patients who have previously treated with a cumulative daunorubicin dose > 25 mg/kg, doxorubicin >500 mg/m2, epirubicin >900mg/m2, pirarubicin > 950mg/m2.
11) a serious or uncontrolled concomitant systematic disorder (active gastric or duodenal ulcer, uncontrolled diabetes mellitus, or cerebral infarction
within 6 months.)
12) Inappropriate patients for this study judged by the physicians

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	FUNAI Kazuhito

Organization

Hamamatsu University School of Medicine

Division name

First Department of Surgery

Zip code

Address

1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Hamamatsu University School of Medicine

Division name

First Department of Surgery

Zip code

Address

1-20-1, Handayama, higashi-ku, Hamamatsu, Shizuoka. Japan

TEL

Homepage URL

Email

Institute

First Department of Surgery, Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

2011

Year

01

Month

06

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

2010

Year

12

Month

22

Day

Date of IRB

2010

Year

12

Month

22

Day

Anticipated trial start date

2011

Year

01

Month

01

Day

Last follow-up date

2021

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

01

Month

06

Day

Last modified on

2022

Year

01

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005753