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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031912
Receipt No. R000036441
Scientific Title Phase 1 study of YM155, novel selective survivin suppressant in combination with elrotinib in patients with EGFR-mutant advanced non-small-cell lung cancer
Date of disclosure of the study information 2018/03/27
Last modified on 2018/03/26

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Basic information
Public title Phase 1 study of YM155, novel selective survivin suppressant in combination with elrotinib in patients with EGFR-mutant advanced non-small-cell lung cancer
Acronym Phase 1 study of YM155 in combination with elrotinib in patients with EGFR-mutant advanced non-small-cell lung cancer
Scientific Title Phase 1 study of YM155, novel selective survivin suppressant in combination with elrotinib in patients with EGFR-mutant advanced non-small-cell lung cancer
Scientific Title:Acronym Phase 1 study of YM155 in combination with elrotinib in patients with EGFR-mutant advanced non-small-cell lung cancer
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Primary endpoints:
- To evaluate the safety and tolerability of YM155 in combination with EGFR-TKI, erlotinib
- To determine DLTs and MTD

Secondary endpoints:
- To evaluate pharmacokinetics (PK) of YM155/erlotinib
- To evaluate preliminary efficacy
- To explore biomarkers analysis including; 1) changes of expression of survivin (IHC) at pre and post administration of YM155, 2) Survivin RT-PCR, 3)Next generation sequencing (NGS) and 4) Luminex analysis of serum proteins
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Primary endpoints:
- To evaluate the safety and tolerability of YM155 in combination with erlotinib
- To determine DLTs and MTD
Key secondary outcomes Secondary endpoints:
- Pharmacokinetics (PK) of YM155/erlotinib
- Preliminary efficacy
- To explore biomarkers analysis including; 1) changes of expression of survivin (IHC) at pre and post administration of YM155 , 2) Survivin RT-PCR, 3)Next generation sequencing (NGS) and 4) Luminex analysis of serum proteins

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 Behavior,custom
Interventions/Control_1 Patients with previously EGFR-TKI treated refractory NSCLC received fix dose of erlotinib (150mg QD) in combination with escalating doses of YM155 (3.6, 4.8, 6.0 and 8.0 mg/m2/d) administered as a continuous intravenous infusion (CIVI) over 168 hours in 21-days treatment cycles.
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 The main eligibility criteria were as follows
A histologically or cytologically confirmed recurrent or metastatic NSCLC patients with documented EGFR exon19 deletion or exon21point mutation who had refractory to EGFR-TKI therapy

Patients must have been >20 years of age with anticipated life expectancy of >12 weeks

ECOG performance status of 0-2

Adequate hematologic, hepatic, and renal functions

No ECG abnormality which needs treatment
Key exclusion criteria The exclusion criteria included the administration of chemotherapy, radiotherapy, or biological therapy in the 4 weeks, 2 weeks for palliative radiotherapy and kinase inhibitors prior to enrollment

Other active malignancies; history or presence of interstitial lung disease; presence of symptomatic brain metastasis; history within 6 months before enrollment or presence of severe cardiovascular or cerebrovascular disease, pulmonary thrombosis, deep vein thrombosis, or other clinically severe pulmonary disease; any of the following complications, including clinically severe infections requiring systemic administration of an antimicrobial agent, antiviral agent or other agents; presence of chronic diarrhea, inflammatory bowel disease or partial ileus; presence of peptic ulcer; fluid retention requiring treatment; uncontrolled diabetes mellitus/hypertension; psychiatric symptoms; appositive test for hepatitis B virus surface antigen, hepatitis C virus antibody or human immunodeficiency virus antibody.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakagawa, M.D., PhD.
Organization Kindai University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama city, Osaka 5898511 Japan
TEL 072-366-0221
Email nakagawa@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Takeda, M.D., PhD.
Organization Kindai University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama city, Osaka 5898511 Japan
TEL 072-366-0221
Homepage URL
Email takedamasa2004@yahoo.co.jp

Sponsor
Institute Department of Medical Oncology, Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 03 Month 27 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 Completed
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 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
2018 Year 03 Month 26 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036441

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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