UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020628 |
|---|---|
| Receipt number | R000023806 |
| Scientific Title | A phase I/II, open-label, single-arm study of CH5424802 for patients with advanced non-small-cell lung cancer harboring a RET fusion gene |
| Date of disclosure of the study information | 2016/01/19 |
| Last modified on | 2022/12/09 11:48:53 |
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Basic information
Public title
A phase I/II, open-label, single-arm study of CH5424802 for patients with advanced non-small-cell lung cancer harboring a RET fusion gene
Acronym
ALL-RET (Alectinib to treat lung cancer harboring a RET fusion gene)
Scientific Title
A phase I/II, open-label, single-arm study of CH5424802 for patients with advanced non-small-cell lung cancer harboring a RET fusion gene
Scientific Title:Acronym
ALL-RET (Alectinib to treat lung cancer harboring a RET fusion gene)
Region
| Japan |
Condition
Condition
Advanced non-small-cell lung cancer harboring a RET fusion gene
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
[Step 1]
To evaluate the safety, tolerability, pharmacokinetic parameters, and efficacy of CH5424802 in patients with advanced non-small-cell lung cancer harboring a RET fusion gene
[Step 2]
To evaluate the efficacy and safety of CH5424802 at the recommended dose in patients with advanced non-small-cell lung cancer harboring a RET fusion gene
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
[Step 1]
1) Dose-limiting toxicity (DLT)
2) Safety
3) Pharmacokinetic parameters
[Step 2]
Objective response rate in RET-tyrosine kinase inhibitor (TKI)-naive patients according to a central review
Key secondary outcomes
[Step 1]
1) Objective response rate in RET-TKI-naive patients according to a central review
2) Response rate according to a review by investigators or sub-investigators
3) Progression-free survival
4) Disease control rate
5) Overall survival
6) Response rate in patients previously treated with RET-TKIs
7) Efficacy in patients harboring different forms of the RET fusion gene
[Step 2]
1) Response rate according to a review by investigators or sub-investigators
2) Safety
3) Pharmacokinetic parameters
4) Progression-free survival
5) Disease control rate
6) Overall survival
7) Response rate in patients previously treated with RET-TKIs
8) Efficacy in patients harboring different forms of the RET fusion gene
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
Administration of CH5424802 (600 mg bid, 450 mg bid, or 300 mg bid) in a cycle of 21 days will continue until criteria for a respite, dosage reduction, or discontinuation of the protocol treatment are met.
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
1. Written informed consent
2. Age 20 or older
3. Histologically or cytologically diagnosed NSCLC
4. Unresectable locally advanced or metastatic disease
5. Tumor samples test positive for a RET fusion gene
6. Testing negative for an EGFR mutation
7. Testing negative for an ALK fusion gene
8. Failure to respond to a course or multiple courses of chemotherapy or progression of NSCLC a course or multiple courses of chemotherapy
9. Life expectancy of 3 months or longer
10. ECOG Performance status of 0-2
11. Female patients of childbearing potential test negative for pregnancy during screening
12. Having adequate bone marrow, liver, renal, and respiratory function
1)Neutrophil count: 1,500/mm3 or higher
2)Hemoglobin: 9.0 g/dL or higher
3)Platelet count: 100,000/mm3 or higher
4)Serum creatinine: 1.5 mg/dL or less
5)ALT, AST, and ALP: Levels 3 times or less the upper limit of normal (local laboratory reference values)
6)Serum bilirubin: Level 1.5 times or less the upper limit of normal (local laboratory reference values)
7)SpO2: 92% or higher
13.Only for Step 2 having one or more measurable lesions in accordance with the revised RECIST guidelines (version 1.1)
Key exclusion criteria
1.Having previously received alectinib
2.A history of hypersensitivity to additives contained in CH5424802
3.Having an infection requiring systemic administration of antibiotics or antivirals
4.Laboratory results positive for HBs antigen or anti-HCV antibodies
5.Unstable brain metastases or spinal cord compression that requires treatment
6.A condition that would preclude receipt of the study treatment
7.A QTc interval greater than 480 msec, a history of long QT syndrome, a history of clinically significant ventricular arrhythmia, currently receiving antiarrhythmic drugs, or having an implanted defibrillator
8.Interstitial lung disease or a history of that disease.
9.Poorly controlled diabetes
10.Hypertension that cannot be managed with medication
11.Female patients who are or may be pregnant
12.Patients who would have difficulty taking medication orally
13.Exhibiting adverse reactions prior to treatment that remain Grade 2 or more severe
14.If the following times have not elapsed from prior to treatment or the conclusion of treatment upon enrollment in this study
1)Surgery or radiation therapy: 4 wks
2)Bronchoscopic treatment: 2 wks
3)Chemotherapy: 4 wks
4)Lenvatinib or vandetanib: 3 wks
5)Nitrosourea or MMC: 6 wks
6)Endocrine therapy or immunotherapy: 2 wks
7)Transfusion or a hematopoietic growth factor: 2 wks
8)Other trial medications: 4 wks
15.Patients with pleural effusion, pericardial effusion, or ascites requiring treatment. This does not apply if, upon enrollment, 2 or more wks have passed since fluid was drained and effusion/ascites has not worsened.
16.Patients with a deep vein thrombus or pulmonary thromboembolism that requires treatment
17.Patients with multiple malignancies with differing histologies. Or patients with a history of those malignancies in the past 5 years.
18.Patients whom an investigator or sub-investigator deems ineligible for participation in this study for some other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Yano |
Organization
Cancer Research Institute, Kanazawa University
Division name
Medical Oncology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL
076-265-2794
syano@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Takeuchi |
Organization
Kanazawa University Hospital
Division name
Cancer Center
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL
076-265-2041
Homepage URL
takeuchi@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Cancer Research Institute, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
CHUGAI PHARMACEUTICAL CO., LTD.
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
国立がん研究センター東病院(千葉県)
がん研究会有明病院(東京都)
名古屋大医学部附属病院(愛知県)
金沢大学附属病院(石川県)
兵庫県立がんセンター(兵庫県)
国立病院機構 九州がんセンター(福岡県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 19 | 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
| 2015 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 19 | Day |
Last modified on
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023806
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