UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039529 |
|---|---|
| Receipt number | R000045081 |
| Scientific Title | All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer- |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2024/07/17 13:55:31 |
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Basic information
Public title
All-Patient General Drug Use Surveillance of Rozlytrek Capsule
-ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Acronym
All-Patient General Drug Use Surveillance of Rozlytrek Capsule
-ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Scientific Title
All-Patient General Drug Use Surveillance of Rozlytrek Capsule
-ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Scientific Title:Acronym
All-Patient General Drug Use Surveillance of Rozlytrek Capsule
-ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Region
| Japan |
Condition
Condition
ROS1 fusion gene-positive unresectable advanced or metastatic non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objectives are to evaluate the following during clinical use of Rozlytrek.
1.Type and time of onset of early symptoms of cognitive disorders (e.g., cognitive disorder, confusional state, mental status changes, memory impairment, hallucination) and ataxia
2.Action taken with Rozlytrek for and outcome of cognitive disorders (e.g., cognitive disorder, confusional state, mental status changes, memory impairment, hallucination) and ataxia
3.Incidence of cardiac disorders (excluding prolonged QT), prolonged QT, syncope, and interstitial lung disease
4.Incidence of serious adverse events not defined in the safety specification
5.Investigator-assessed response rate
Safety concerns defined in the safety specification: Cognitive disorders/ataxia, cardiac disorders (excluding prolonged QT), prolonged QT, syncope, interstitial lung disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
1.Incidence of early symptoms of cognitive disorders or ataxia by type
2.Time of onset of early symptoms of cognitive disorders or ataxia (e.g., basic statistics)
3.Proportion of patients requiring action with respect to Rozlytrek (e.g., treatment interruption, treatment discontinuation) at onset of cognitive disorder or ataxia
4.Outcome rate (e.g., recovered, improved) by action taken with Rozlytrek (treatment interruption, treatment discontinuation) at onset of cognitive disorder or ataxia
5.Incidence of ADRs by type (by MedDRA PT, by safety concern defined in the safety specification)
Effectiveness:
1.Investigator-assessed response rate (Assess response using RECIST.)
2.Investigator-assessed response rate in patients with ROS1 fusion gene mutations (Assess response using RECIST.)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients eligible for enrollment: All patients with ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer who are planning to use Rozlytrek during the enrollment period.
Patients eligible for case report form (CRF) collection: All patients eligible for enrollment who receive Rozlytrek
CRFs will be collected for all patients with ROS1 fusion gene-positive unresectable advanced non-small cell lung cancer who receive Rozlytrek. Data will also be collected retrospectively from patients with ROS1 fusion gene-positive unresectable advanced non-small cell lung cancer who receive Rozlytrek before conclusion of the agreement for this surveillance study.
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nomura |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
nomuramkt@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ryousuke |
| Middle name | |
| Last name | Harada |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
haradarus@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2020 | Year | 02 | Month | 21 | 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
| 2020 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045081
