UMIN-CTR Clinical Trial

Public title

Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Acronym

Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Scientific Title

Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Scientific Title:Acronym

Phase I study of Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Region

Japan

Condition

ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Classification by specialty

Pneumology

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The objectives of this study is To determine the recommend dose of Erlotinib and Crizotinib, and to investigeate the efficacy and safety of the recommend dose for Erlotinib and Crizotinib after ALK inhibitor failure in ALK positive advanced Non-Small Cell Lung Cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

safety

Key secondary outcomes

Response rate, disease control rate,
progression free survival,
overall Survival,

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

Erlotinib and Crizotinib combinationtherapy

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Non-small cell lung cancer proven by histology and/or cytology and ALK positive lung cancer by IHC or FISH or RT-PCR.
2))Patients who have previously treated with ALK inhibiter more than 3 weeks and
3) With one or more measurable disease based on RECIST (ver.1.1)
4) Performance Status (ECOG) : 0-1
5) 20<= years
6) Patients providing written informed consent
7) Adequate function of vital organs, including normal hematopoietic liver
and renal function as following:
WBC >= 3,000/mm3 or Neutrophils >= 1,500/mm3
Hemoglobin >= 9.0 g/dL
Platelets >= 100,000/mm3
AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
Total bilirubin <= 1.5mg/mL
Serum creatinine <= 1.5mg/dL
Creatinin crealance>=30mL/min
PT-INR <1.5
Urinary protein <2+
PaO2>=60torr or SpO2>=95%

8)interval:
(1) chemotherapy, more than 3 weeks after the last chemotherapy.
(2) Radiation, more than 12 weeks after the thoracic irradiation or more than 2 weeks after the last irradiation to other organs.
(3) Operation, more than 4 weeks after the last operation (including pleurodesis)
9) A life expectancy of more than 3 months

Key exclusion criteria

1)No prior treatment with EGFR-TKI
2)Patients with uncontrollable complications(e.g. uncontrollable heart disease, severe arrhythmia, continuous diarrhea).
3)Patients with active severe brain metastasis.
4)1)Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
5)History of active double cancer within 5 years prior to the study.
6)Patients with symptomatic brain metastasis
7)Impossible cases with oral administration.
8)Pregnancy or lactation
9) Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Makot Nishio

Organization

Cancer institute hospital, Japanese Foundation For Cancer Reseach

Division name

Medical thoracic oncology

Zip code

Address

Kouto-ku ariake 3-8-31, Tokyo, Japan

TEL

03-3520-0111

Email

mnishio@jfcr.or.jp

Name of contact person

1st name
Middle name
Last name	Keita Kudo

Organization

Cancer institute hospital, Japanese Foundation For Cancer Reseach

Division name

Medical thoracic oncology

Zip code

Address

Kouto-ku ariake 3-8-31, Tokyo, Japan

TEL

03-3520-0111

Homepage URL

Email

keita.kudo@jfcr.or.jp

Institute

Medical thoracic oncology, Cancer institute hospital, Japanese Foundation For Cancer Reseach

Institute

Department

Personal name

Organization

Medical thoracic oncology, Cancer institute hospital, Japanese Foundation For Cancer Reseach

Organization

Division

Category of Funding Organization

Non profit foundation

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

2013

Year

02

Month

21

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

Terminated

Date of protocol fixation

2012

Year

12

Month

13

Day

Date of IRB

Anticipated trial start date

2013

Year

03

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

2013

Year

02

Month

21

Day

Last modified on

2019

Year

02

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011766