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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002570
Receipt No. R000003099
Scientific Title Phase II study of weekly amrubicin in patients with refractory or relapsed non-small cell lung cancer
Date of disclosure of the study information 2009/10/01
Last modified on 2014/05/08

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Basic information
Public title Phase II study of weekly amrubicin in patients with refractory or relapsed non-small cell lung cancer
Acronym Phase II study of weekly amrubicin for non-small cell lung cancer patients
Scientific Title Phase II study of weekly amrubicin in patients with refractory or relapsed non-small cell lung cancer
Scientific Title:Acronym Phase II study of weekly amrubicin for non-small cell lung cancer patients
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate the safety and toxicity with the weekly amrubicin hydrochloride, in patients with chemotherpy-refractory or recurrent non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Evaluation of safety, progression free survival, disease control rate two months later

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 Weekly 60mg/ m2 (repetition of dose on 1st/8th day with 15th day rest) administration of amrubicin hydrochlorid
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically proven non-small cell lung cancer
2. Refractory to first- or second-line chemotherapy patients or relapsed patients
3. Age over 19 years
4. ECOG Performance Status of 0 to 2
5. With measurable lesion
6. Adequate main organ functions ( WBC >= 3000/uL, Neutrophils >= 1500/uL, Hb >= 9.0 g/dL, Platelets >= 100000/uL, AST and ALT <= two times upper normal limit, Total bilirubin <= 1.5mg/dL, Serum creatinine <= normal limit, SpO2 >= 90%, Left ventricular ejection fraction >= 60%)
7. Written informed consent
Key exclusion criteria 1. Contraindication for amrubicin
2. Carcinomatous pleuritis, pericarditis, peritonitis and other metastasis with local therapy indication
3. Patient can not enroll during radiotherapy, but can be registered after interval (chest: four weeks; without chest: one weeks).
4. Serious medical complication: Uncontrolled angina pectoris, myocardial infarction for less than 3 months, patient with cardiac failure. Uncontrolled diabetes mellitus, hypertension.
5. Infected patients
6. Other clinical difficulties in this study
Target sample size 43

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideo Saka
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address 4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL 052-951-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chiyoe Kitagawa
Organization National Hospital Organization Nagoya Medical Center
Division name Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email kitagawc@nnh.hosp.go.jp

Sponsor
Institute National Hospital Organization Nagoya Medical Center
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2009 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2015 Year 04 Month 01 Day
Date of closure to data entry
2015 Year 07 Month 01 Day
Date trial data considered complete
2015 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 01 Day
Last modified on
2014 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003099

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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