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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001101
Receipt No. R000001302
Scientific Title Phase I study of weekly amrubicin in patients with refractory or relapsed lung cancer
Date of disclosure of the study information 2008/04/20
Last modified on 2008/12/17

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

Condition
Condition lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate the safety and tolerability, to determine the recommended weekly amrubicin dose, and to conduct a pharmacokinetic study in patients with chemotherpy-refractory or recurrent lung cancer.
Basic objectives2 Others
Basic objectives -Others response rate
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Evaluation of safety
Pharmacokinetic study at the first cycle
Key secondary outcomes Response rate in assessable patients

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Weekly (repetition of dose on 1st/8th day with 15th day rest) administration of amrubicin hydrochloride
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Histologically or cytologically proven lung cancer
2. Refractory to first- or second-line chemotherapy patients or relapsed patients
3. Age over 19, and less than 80
4. Performance Status (ECOG): 0 to 2
5. Adequate main organ functions
WBC>=4000/uL
Neutro>=2000/uL
Hgb>=9.0 g/dL
Platelets>=100000/uL
AST, ALT: less than two times the upper normal limit
T. Bil <=1.5 mg/dL
s-Cr: less than upper normal limit
SpO2 >= 90%
Left ventricular ejection fraction >=60%
6. Postoperative recurrence and asymptomatic brain metastasis
7. Written informed consent
Key exclusion criteria 1. Contraindication for amrubicin
2. Carcinomatous pleuritis, pericarditis, pritonitis 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 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chiyoe Kitagawa
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

Sponsor
Institute Central Japan Lung Study Group
Institute
Department

Funding Source
Organization Central Japan Lung Study Group
Organization
Division
Category of Funding Organization Non profit foundation
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
2008 Year 04 Month 20 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
The maximum tolerated dose (MTD) was 65 mg/m2.The recommended dose (RD) was determined 60 mg/m2.
Dose limiting toxicity was neutropenia and serum transaminase elevation.
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
2006 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2008 Year 08 Month 01 Day
Date of closure to data entry
2008 Year 09 Month 01 Day
Date trial data considered complete
2008 Year 09 Month 01 Day
Date analysis concluded
2008 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 27 Day
Last modified on
2008 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001302

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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