UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036395 |
|---|---|
| Receipt number | R000041465 |
| Scientific Title | Phase I / IIa trial of R-OKY-034F for pancreatic cancer patients |
| Date of disclosure of the study information | 2019/04/03 |
| Last modified on | 2021/10/04 10:09:21 |
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Basic information
Public title
Phase I / IIa, single-institution, open-label study to explore the safety and efficacy of R-OKY-034F in patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapy
Acronym
Phase I / IIa, single-institution, open-label study to explore the safety and efficacy of R-OKY-034F in patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapy
Scientific Title
Phase I / IIa trial of R-OKY-034F for pancreatic cancer patients
Scientific Title:Acronym
Phase I / IIa trial of R-OKY-034F for pancreatic cancer patients
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determination of dose-limiting toxicity (DLT) of R-OKY-034F by oral administration of R-OKY-034F orally once daily for patients with refractory / intolerable and surgically unresectable pancreatic cancer with standard chemotherapy And estimate the maximum tolerated dose (MTD) and assess safety to determine the recommended dose (RD) for clinical trials after Phase IIb.
Also, preliminary search for effectiveness.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
<safety>
1) Determination of dose-limiting toxicity (DLT) of R-OKY-034F
2)Determination of the maximum dose (MTD) of R-OKY-034F
<Effectiveness>
1) Calculation of response rate and disease control rate for each dose when R-OKY-034F is administered
Key secondary outcomes
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
R-OKY-034F
once a day for 28 days orally
1, 2.5, 5, 10, 15 mg/kg
Post-observation period: 14 days
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Disease
Patients who have been diagnosed with pancreatic ductal cancer pathologically or histologically
2) Clinical stage of disease
Image diagnosis by contrast-enhanced CT or contrast-enhanced MRI within 14 days prior to registration, "Diagnoses of Pancreatic cancer medical care guidelines 2016 edition: How is the resectability of pancreatic cancer determined?" Patient Patients who are refractory or intolerant of both gemcitabine-based standard chemotherapy and 5-FU-based standard chemotherapy and have no other standard chemotherapy available
3) Age
Patients aged 20 and over and under 80 at the time of enrollment
4) PS: Performance status
Patients with PS 0 to 2
5) Evaluation possibility of lesion
Patients with one or more measurable lesions defined by RECIST criteria
6) Consent
Patients who have obtained informed consent from patients themselves regarding clinical trial participation
7) prognosis
Patients with a prognosis of more than 2 months
Key exclusion criteria
1) Duplicate cancer
Patients with active double cancer. However, we do not exclude duplicate cancers that do not affect safety and efficacy assessment.
2) Items related to complications
* Patients with unstable angina (angina pectoris onset or attack worsening within 3 weeks before enrollment), or patients with a history of myocardial infarction within 6 months
* Patients with QtcE prolongation of 450 ms or more
* Patients with interstitial lung disease or patients with previous history
* Patients with high degree of disability due to respiratory disease (interstitial lung disease, radiation lung injury etc.) (grade 3 or higher on the modified MRC scale)
* Patients with high physical activity restriction due to heart failure (NYHA class III or higher)
* Patients with intestinal paralysis, intestinal obstruction or severe diarrhea
* Patients who have the following abnormal values for kidney function, liver function and bone marrow function at screening test
- Moderate or higher renal dysfunction with GFR estimate less than 45 ml / min / 1.73 m2
- Moderate or more liver dysfunction, with either AST or ALT> 100 IU / L
- Leukocytes: less than 3,000 / microL
- Neutrophils: less than 1,500 /microL
- Platelet: less than 75,000 / microL
- Hemoglobin: less than 8.0 g / dL
- Total bilirubin: 2.5 mg / dL or more
* Patients weighing less than 40 kg
* Pregnant women
* Breastfeeding women (It is not this limitation if it is possible to refrain from breastfeeding for 14 days after the final oral administration from the study drug oral administration start date)
* Patients who are complicated by psychosis or psychiatric symptoms and judged as difficult to participate in clinical trials
3) Other
* Women and men who can not agree to the practice of highly effective contraception
* Patients who the investigator or subinvestigator judged as inappropriate for trial entry
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-15 Yamadaoka, Suita, Osaka
TEL
06-6879-5111
lat1.office@dmi.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Harada |
Organization
Osaka University
Division name
Department of Medical Innovation
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6210-8289
Homepage URL
lat1.office@dmi.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-15 Yamadaoka, Suita, Osaka
Tel
06-6210-8290
jim-chiken@hp-crc.med.osaka-u.ac.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
| 2019 | Year | 04 | Month | 03 | 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
| 2018 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 03 | Day |
Last modified on
| 2021 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041465
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| Registered date | File name |
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| Registered date | File name |
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