UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031912 |
|---|---|
| Receipt number | 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 23:38:32 |
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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
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
takedamasa2004@yahoo.co.jp
Sponsor or person
Institute
Department of Medical Oncology, Kindai University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036441
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