UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049555 |
|---|---|
| Receipt number | R000056403 |
| Scientific Title | Phase II study to evaluate the efficacy and safety of mirogabalin for CIPN in patients with gastrointestinal cancer. |
| Date of disclosure of the study information | 2022/11/18 |
| Last modified on | 2024/03/14 20:47:44 |
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Basic information
Public title
Phase II study to evaluate the efficacy and safety of mirogabalin for CIPN in patients with gastrointestinal cancer.
Acronym
Phase II study to evaluate the efficacy and safety of mirogabalin for CIPN in patients with gastrointestinal cancer.
Scientific Title
Phase II study to evaluate the efficacy and safety of mirogabalin for CIPN in patients with gastrointestinal cancer.
Scientific Title:Acronym
Phase II study to evaluate the efficacy and safety of mirogabalin for CIPN in patients with gastrointestinal cancer.
Region
| Japan |
Condition
Condition
esophageal cancer, gastric cancer, small bowel cancer, colon cancer, pancreatic cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of mirogabalin in patients with unresectable/recurrent gastrointestinal cancer with peripheral neuropathy induced by oxaliplatin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Change in 24-hour pain (including numbness) average NRS (Numeric Rating Scale) from the start of mirogabalin administration to 6 weeks.
Key secondary outcomes
- Rate of improvement in peripheral sensory neuropathy severity (CTCAE ver5.0 Grade) after 3, 6, and 12 weeks from the start of mirogabalin administration as a baseline
- Changes in FACT/GOG NTx after 3 weeks, 6 weeks, and 12 weeks from the start of mirogabalin administration
- Change in pain (including numbness) NRS from 3 weeks to 12 weeks after the start of mirogabalin administration as a baseline
- Changes in PHQ9 after 3 weeks, 6 weeks, and 12 weeks from the start of mirogabalin administration
-Percentage of achievement of personalized pain goal (PPG) after 3 weeks, 6 weeks, and 12 weeks from the start of mirogabalin administration
- Chemotherapy dose reduction, drug interruption, and discontinuation rate from the start of mirogabalin administration to 12 weeks later
- Adverse events (CTCAE ver.5.0)
- Percentage reaching maintenance dose of mirogabalin at 3, 6 and 12 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Initial dose of mirogabalin orally twice daily, then titrated at intervals of at least 1 week to a maintenance dose orally twice daily.
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) Unresectable advanced or recurrent gastrointestinal cancer (gastric cancer, colon cancer, pancreatic cancer, esophageal cancer, small bowel cancer) Histologically diagnosed.
2) Age at the time of registration is 20 years or older.
3) Performance Status (ECOG) is 0-2.
4) Patients who have no history of systemic chemotherapy as first-line therapy. (Patients with a history of preoperative or postoperative chemotherapy may be enrolled if there is no residual cancer after surgery (R0 resection) and the last administration is 180 days or more before the confirmed date of recurrence.)
5) Started first-line therapy with oxaliplatin-containing regimen and is continuing treatment, or is continuing first-line therapy mainly with fluoropyrimidines after stopping oxaliplatin.
6) CIPN pain (including numbness) NRS of 4 or higher at enrollment.
7) Patients who have not used mirogabalin within 28 days before enrollment.
8) Oral intake is possible.
9) Written consent has been obtained from the patient to participate in the study.
Key exclusion criteria
1)Patients diagnosed with diabetic neuropathy.
2)Patients with cervical or lumbar spondylosis causing neuropathic pain.
3)Patients with creatinine clearance (Cockcroft-Gault formula)less than 30 mL/min at enrollment.
4)Women who are pregnant or breast-feeding, who need to continue breast-feeding after starting study drug administration, or who may be pregnant.
5)Patients with a history of hypersensitivity reaction to mirogabalin besilate.
6)Concomitant use of the following drugs:
pregabalin, gabapentin, Tricyclic antidepressants: amitriptyline, nortriptyline, imipramine, clomipramine, SNRIs: duloxetine, venlafaxine, milnacipran, Antiepileptic drugs: carbamazepine, sodium valproate, lamotrigine, topiramate, clonazepam, Kampo medicine: goshajinkigan Other: cimetidine, probenecid.
7)Patients who newly added the following drugs or changed the dose (increase or decrease) by 10% or more within 14 days before registration. Opioid analgesics, tramadol, NSAIDs, acetaminophen.
8)Patients who are complicated by psychosis or psychiatric symptoms that interfere with daily life and are judged to be difficult to participate in the study.
9)In addition, those who are judged to be inappropriate as research subjects by the principal investigator or co-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kato |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1. Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
kenkato@ncc.go.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Shoji |
Organization
National Cancer Center Hospital
Division name
Department of Gastrointestinal Medical Oncology
Zip code
104-0045
Address
5-1-1. Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
hshouji@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Research Ethics Committee
Address
National Cancer Center Hospital
Tel
03-3542-2511
irst@ml.res.ncc.go.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2022 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056403
