UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006273 |
|---|---|
| Receipt number | R000007427 |
| Scientific Title | A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation |
| Date of disclosure of the study information | 2011/09/02 |
| Last modified on | 2014/09/02 12:49:19 |
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Basic information
Public title
A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation
Acronym
A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation
Scientific Title
A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation
Scientific Title:Acronym
A phase I study of pemetrexed and gefitinib in chemotherapy naive elderly patients with non- small cell lung cancer harboring EGFR mutation
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the maximum tolerated dose (MTD) of pemetrexed and gefitinib in chemotherapy naive 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 I
Assessment
Primary outcomes
Maximum tolerated dose (MTD) of pemetrexed and gefitinib
Key secondary outcomes
Anti tumor efficacy
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
Level 1 gefitinib250mg/day and pemetrexed (300mg/m2)
Level 2 gefitinib250mg/day and pemetrexed (400mg/m2)
Level 3 gefitinib250mg/day and pemetrexed (500mg/m2)
If none of the 3 patients who had been originally allocated to a dosage level experienced
DLT, the dose of pemetrexed 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 experienced 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
Eligibility
Age-lower limit
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histology/cytology-proven non-small cell lung cancer, age of 70 years or over
2)NSCLC harboring mutations of EGFR
3)Stage IIIB, IV
4)Chemotherapy naïve patients
5)Performance status(ECOG): 0-1
6)Adequate organ function
7)Written informed consent
Key exclusion criteria
1)Serious infections
2)Serious clinical problems
3)Interstitial pneumonia/lung fibrosis on chest CT
4)Active concomitant malignancy
5)Symptomatic brain metastasis
6)Massive pericardial, pleural effusion, ascites
7)Previous drug allergy
8)Those judged to be not suitable by the attending physician
Target sample size
11
Research contact person
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
092-852-0700
ichiki@kyumed.jp
Public contact
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
1-8-1 Jigyohama Chuo-ku, Fukuoka 810-8563, Japan
TEL
092-852-0700
Homepage URL
ichiki@kyumed.jp
Sponsor or person
Institute
National Hospital Organization Kyushu Medical Center
Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kyushu Medical Center
Department of Respiratory Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 02 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 02 | Day |
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 02 | Day |
Last modified on
| 2014 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007427
