UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029854 |
|---|---|
| Receipt number | R000033998 |
| Scientific Title | Phase 1 study of immune checkpoint inhibitor Nivolumab in combination with Bezafibrate in pretreated advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2017/11/07 |
| Last modified on | 2020/04/09 17:49:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase 1 study of immune checkpoint inhibitor Nivolumab in combination with Bezafibrate in pretreated advanced non-small cell lung cancer
Acronym
Phase 1 study of Nivolumab and Bezafibrate in pretreated advanced non-small cell lung cancer
Scientific Title
Phase 1 study of immune checkpoint inhibitor Nivolumab in combination with Bezafibrate in pretreated advanced non-small cell lung cancer
Scientific Title:Acronym
Phase 1 study of Nivolumab and Bezafibrate in pretreated advanced non-small cell lung cancer
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer
(Stage III/IV or postoperative recurrent)
Classification by specialty
| Pneumology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety of Nivolumab in combination with Bezafibrate and determine a recommended dose (RD) of bezafibrate in patients with pretreated advanced non-small cell lung cancer (NSCLC)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Percentage of patients with dose-limiting toxicity (DLT)
Key secondary outcomes
Percentage of patients with at least 1 adverse event
Response rate (RR)
Progression-free survival (PFS)
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
Two weeks of the following regimen consist of one course. Administer Nivolumab (240mg) by DIV on day 1, and oral dose of Bezafibrate at 100 mg BID. or 200 mg BID on day 1, 5, 8 and 12, and continue treatment up to 3 courses unless any of the discontinuation criteria of protocol treatment is applicable.
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.confirmed histologically or cytologically as NSCLC
2. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
3.Clinical stage III or IV or postoperative recurrent NSCLC that has been previously treated with at least one cytotoxic drug-included regimen.
4.About patients with NSCLCs harbouring driver oncogenes such as EGFR, they need to have been treated with at least one appropriate TKI.
5. Aged 20 years or older at the time of informed consent.
6. All of the following criteria are met based on the latest data obtained within 14 days before enrollment
1) Leucocyte count >= 2,000/microliter
2) Neutrophil count >= 1,000/microliter
3) Hemoglobin >= 8.0 g/dL
(Transfusion is not performed within 14 days before enrollment.)
4) Platelet count >= 10X10^4/microliter
5) Total bilirubin <= 1.5 mg/dL
6) AST (GOT) <= 100 IU/L
7) ALT (GPT) <= 100 IL/L
8) Serum creatinine <=1.5 mg/dL
9) SpO2 >= 92% at room air. Patients with SpO2 < 92% are eligible if PaO2 is >= 60 torr.
7. Able to swallow oral medications.
Key exclusion criteria
1. Patients with an infection requiring systemic treatment.
2. Patients with the history of hypersensitivity to Bezafibrate, Polysorbate 80 that is the component of Nivolumab, and other drugs.
3. Patients with clinically significant psychiatric disease or symptom that would interfere with participation in this study.
4. Patients treated with administration of steroid equivalent to more than 10 mg /day predonine, or an immune suppressor (oral or intravenous) within 14 days before enrollment. Patients who do not suffer from current autoimmune diseases and are treated with inhalation or topical administration of steroid or patients with steroid equivalent to more than 10 mg /day predonine as adrenal cortex hormone replacement are eligible.
5. Patients with current or suspicious autoimmune diseases.
6. Patients with symptomatic brain metastases.
7. Patients with carcinomatous meningitis.
8. Active double cancer
9. Patients with unstable angina or poorly controlled hypertension or diabetes mellitus.
10. Patients with positive for hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody.
11. Patients with distinct interstitial pneumonitis or pulmonary fibrosis based on chest CT.
12 Patients whose withdrawal of HMG-CoA inhibitors during this trial are not allowed.
13. Patients with history of previous immune checkpoint inhibitor treatment including Nivolumab.
14. Pregnant or lactating females. Females of child-bearing potential with the positive result of the urine pregnancy test that was carried out within 14 days before enrollment.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Isamu |
| Middle name | |
| Last name | Okamoto |
Organization
Kyushu University Hospital
Division name
Research Institute for Diseases of the Chest
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5378
okamotoi@kokyu.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Isamu |
| Middle name | |
| Last name | Okamoto |
Organization
Kyushu University Hospital
Division name
Research Institute for Diseases of the Chest
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL
092-642-5378
Homepage URL
okamotoi@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development:AMED
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Institutional Review Board
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
Tel
092-642-5774
ishida.eik@iberica.co.jp
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
九州大学病院（福岡県）Kyushu University Hospital
熊本大学病院（熊本県）Kumamoto University Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 07 | 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
18
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
| 2017 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033998
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
