UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022252
Receipt number R000025635
Scientific Title Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)
Date of disclosure of the study information 2016/05/10
Last modified on 2016/08/17 16:35:17

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Basic information

Public title

Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)

Acronym

Phase II study of low-dose afatinib for elderly NSCLC patients

Scientific Title

Phase II study of low-dose afatinib for elderly patients with non-small cell lung cancer harboring EGFR mutation (based on TDM)

Scientific Title:Acronym

Phase II study of low-dose afatinib for elderly NSCLC patients

Region

Japan


Condition

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of low dose afatinib (20mg/day) for elderly patients with non-small cell lung cancer harboring EGFR mutation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Progression-free survival

Key secondary outcomes

Response rate, Overall survival, Incidence of adverse events, PK analysis


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

1) Treatment with afatinib at a dose of 20 mg daily (until PD).
2) At day 7-14 after the start of afatinib, samples for pharmacokinetc analyses will be obtained (9 points).
3) Afatinib were permitted to dose escalate, if patients did not experience Gr 1 diarrhea and Gr 1 anorexia with trough concentration of afatinib < 15 ng/mL at day 7-14.

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

75 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Pathologically confirmation of non small cell lung cancer
2) Clinical stage IIIB, IV, or postoperative recurrence
3) With activating EGFR mutation (Deletion in exon 19 or L858R in exon 21)
4) ECOG performance status 0-2
5) No prior therapy of EGFR-TKI
6) Measurable lesions based on RECIST ver1.1
7) Adequate organ functions
8) Written informed consent

Key exclusion criteria

1) Interstitial lung disease
2) Receiving continuous systemic corticosteroid
3) During pregnancy or lactation
4) Psychological disorder difficult to participate in this clinical study

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki Takahashi

Organization

Shizuoka Cancer Center

Division name

Division of Thoracic Oncology

Zip code


Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun

TEL

055-989-5222

Email

t.takahashi@scchr.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirotsugu Kenmotsu

Organization

Shizuoka Cancer Center

Division name

Division of Thoracic Oncology

Zip code


Address

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun

TEL

055-989-5222

Homepage URL


Email

h.kenmotsu@scchr.jp


Sponsor or person

Institute

Shizuoka Cancer Center

Institute

Department

Personal name



Funding Source

Organization

Grants-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine

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

静岡県立静岡がんセンター(静岡県)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 10 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

Open public recruiting

Date of protocol fixation

2016 Year 03 Month 30 Day

Date of IRB


Anticipated trial start date

2016 Year 08 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 09 Day

Last modified on

2016 Year 08 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025635


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name