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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018674
Receipt No. R000021622
Scientific Title Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer
Date of disclosure of the study information 2015/08/14
Last modified on 2015/08/17

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Basic information
Public title Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer
Acronym Phase I study of amrubicin and paclitaxel
Scientific Title Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer
Scientific Title:Acronym Phase I study of amrubicin and paclitaxel
Region
Japan

Condition
Condition NSCLC
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We conducted a phase I dose escalation study to determine the maximum dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small-cell lung cancer (NSCLC).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Doses were escalated according to the frequency of dose limiting toxicity (DLT) evaluated the first cycle of chemotherapy. At least three patients were enrolled at each dose level. Initially, 3 patients were treated at dose level 1, and no intra-patient dose escalation was allowed. If one DLT was observed in the first three patients, 3 more patients were entered at this dose level and dose escalation continued to the next level if fewer than 3 of 6 patients experienced DLT. The MTD was defined as the previous level from the level at which DLT was observed in 2 out of 3 or in 3 out of 6 patients. If 2 out of 3 or 3 out of 6 patients experienced a DLT at level 1, a dose reduction to level 0 was planned. DLT was defined as: (1) grade 4 neutropenia lasting longer than 4 days; (2) grade 4 thrombocytopenia; (3) grade 3 febrile neutropenia; (5) grade 3 or worse nonhematologic toxicities except nausea/vomiting; (6) any unresolved toxicity requiring a delay in the administration of a subsequent cycle exceeding 14 days; and (7) any grade 2 toxicity which, in the judgement of the investigator, required dose reduction or discontinuation of therapy.
Key secondary outcomes Response, biomarker

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 All patients were treated with AMR and PTX every 4 weeks. PTX was administered at a fixed dose of 150 mg/m2/day on day 1, and AMR was intravenously administered at a starting dose of 25 mg/m2/day on days 1 to 3. Subsequent dose levels were 25 mg/m2 (level 1) and 30 mg/m2 (level 2 and 3)
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 Eligible patients were required to have: histologically and/or cytologically proven NSCLC; recurrent or refractory disease after one or two previous chemotherapy regimens; a performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group; an age with ;20 years; a life expectancy of 8 weeks or more; adequate bone marrow reserve (leukocyte count , absolute neutrophil count ;1500 mm-3, platelet count ;100000 mm-3, and hemoglobin 9 g dL-1); adequate function (total serum bilirubin ;1.5 mg dL-1, aspartate transaminase (AST), alanine transaminase (ALT) less than twice the upper limit of the normal range and serum creatinine ;1.5 mg dL-1); ECG findings within the normal range, and a left ventricular ejection fraction ;50%; arterial oxygen partial pressure ;60 torr.
Key exclusion criteria Patients with concomitant malignancy, central nervous system metastases, active infectious diseases or other serious medical problems were ineligible.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Hospital
Division name respiratory medicine
Zip code
Address Maebashi, Gunma , Japan
TEL 027-220-8136
Email kkaira1970@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Kaira
Organization Gunma University Hospital
Division name respiratory medicine
Zip code
Address Maebashi, Gunma , Japan
TEL 027-220-8136
Homepage URL
Email kkaira1970@yahoo.co.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Gunma University
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
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
2015 Year 08 Month 14 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
2013 Year 02 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 03 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
2015 Year 08 Month 14 Day
Last modified on
2015 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021622

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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