UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002570 |
|---|---|
| Receipt number | 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 20:51:52 |
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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
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
kitagawc@nnh.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nagoya Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003099
