UMIN-CTR Clinical Trial

Public title

A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.

Acronym

A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.

Scientific Title

A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.

Scientific Title:Acronym

A phase 1 study of cisplatin/pemetrexed/crizotinib followed by maintenance crizotinib in patients with stage 3B or 4 EML4-ALK positive non-small-cell lung cancer.

Region

Japan

Condition

Chemo-naïve advanced ALK positive NSCLC

Classification by specialty

Hematology and clinical oncology

Adult

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To assess the safety of cisplatin and pemetrexed and crizotinib in patients with advanced ALK positive NSCLC

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Maximum Tolerated schedule of crizotinib with cisplatin and pemetrexed

Key secondary outcomes

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

cisplatin (75mg/m2) + pemetrexed (500mg/m2)
level 1: crizotinib 200mg twice daily
day1-7
level 2: crizotinib 250mg twice daily
day1-7
level 3: criztotinib 250mg twice daily
day1-14
level 4: crizotinib 250mg twice daily
day 1-21
level 5: crizotinib 250mg twice daily

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)Histologically or cytologically confirned non-small-cell lung cancer (NSCLC)
2)Diagnosed EML4-ALK positive by Fish or PCR
3)With measurable lesion
4)Stage IIIB without any indications for radiotherapy or Stage IV or recurrent disease after surgery or radiotherapy who have no prior chemoterapy
5)20 years old or older
6)ECOG PS 0-1 or older
7)Adequate organ function
8)Life expectancy more than 3 months
9)Signed informed consent

Key exclusion criteria

1)Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray
2) History of poorly controlled pleural effusion,pericardial effusion and ascites
3)Not appropriate to receive the folic acid and vitamin B12 formulation
4)SVC syndrome
5)Symptomatic brain metastases
6)History of active double cancer
7)Uncontrollable diabetes mellitus and hypertension
8)Diagnosed as liver cirrhosis by image findings or clinical laboratory
9)Suffers from an infectious disease to need antibiotic treatment
10)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc within 6 months)
11)Pregnant female or sexually active males/females unwilling to use contraception during the protocol treatment
12)History of grave drug allergic reaction
13)Acute inflammatory disease
14)An agreement is not obtained for support therapy such as transfusion etc.
15)History of active psychological disease
16)Having the bleeding tendency which is clear in clinic
17)Taking continuous whole body administration (oral administration or intravenous administration) of steroid
18)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Shinji Atagi

Organization

National organization Kinki-chuo chest medical center

Division name

medical oncology

Zip code

Address

1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN

TEL

072-252-3021

Email

Name of contact person

1st name
Middle name
Last name	Kazuhiro Asami

Organization

National organization Kinki-chuo chest medical center

Division name

medical oncology

Zip code

Address

1180 Nagasone-cho, Kita-ku, Sakai-city, Osaka591-8555 JAPAN

TEL

072-252-3021

Homepage URL

Email

asami@kch.hosp.go.jp

Institute

National organization Kinki-chuo chest medical center

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

2012

Year

11

Month

05

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

Open public recruiting

Date of protocol fixation

2012

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

05

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

11

Month

03

Day

Last modified on

2012

Year

11

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010868