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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000046619 |
Receipt No. | R000045060 |
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 | 2022/01/13 |
Last modified on | 2022/08/01 |
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- |
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Acronym | All-Patient General Drug Use Surveillance of Rozlytrek Capsule
-ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer- |
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Scientific Title | All-Patient General Drug Use Surveillance of Rozlytrek Capsule
-ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer- |
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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- |
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Region |
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Condition | ||
Condition | ROS1 fusion gene-positive unresectable advanced or metastatic non-small cell lung cancer | |
Classification by specialty |
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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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | None | |||
Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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Organization | Chugai Pharmaceutical Co. Ltd. | ||||||
Division name | Real World Data 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 | |
Institute | Chugai Pharmaceutical Co. Ltd. |
Institute | |
Department |
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 |
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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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | None |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045060 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |