UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025844 |
|---|---|
| Receipt number | R000029709 |
| Scientific Title | Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study |
| Date of disclosure of the study information | 2017/01/25 |
| Last modified on | 2018/12/06 15:30:11 |
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Basic information
Public title
Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study
Acronym
Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study
Scientific Title
Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study
Scientific Title:Acronym
Gemcitabine and MK615 combination therapy in unresected advanced pancreatic cancer.: A pilot study
Region
| Japan |
Condition
Condition
unresected advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate safety and tolerability of Gemcitabine and MK615 combination therapy in patients with unresected advanced pancreatic cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety: AEs
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
| Food |
Interventions/Control_1
Gemcitabine
1000 mg/m2 IV one time over 30 minutes.
Weekly dosing on Days 1, 8, and 15 of 28 day cycles. If severe toxicity occurs, a dose should be reduced (1000mg, 800mg, 600mg).
MK615
MK615 will be administered orally daily 3 packets, until any discontinuation criteria has been met. A treatment cycle will be 28 days.If severe toxicity occurs, a dose should be reduced (3, 2, 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histopathologically confirmed pancreatic cancer(adenocarcinoma and adenosquamous carcinoma)
2) Not resectable metastatic pancreatic cancer and No prior Gemcitabine-containing chemotherapy
3) ECOG performance status of 0, 1 or 2
4) 20<= years old
5) Expected survival period is more than 3 months
6) The organ function must be kept within 14 days before registration
6-1 leukocyte >= 3,000/mcL
6-2 neutrophil >=1,500/mcL
6-3 platelet >=75,000/mcL
6-4 hemoglobin >=8.0 g/dL.
6-5 T-Bilirubin >=2.0 mg/dL
6-6 AST =<100 IU/L (AST =<300 IU/L with liver metastasis)
6-7 ALT =<100 IU/L (ALT =<300 IU/L with liver metastasis)
6-8 serum creatinine =<2.5 mg/dL
7) written informed consent got from the patient
Key exclusion criteria
1) Active concomitant malignancy or history of another malignancy within the last 5years
2) Symptomatic brain metastasis
3) Severe infectious diseases
4) Subjects with the past history of Interstitial pneumonia or pulmonary fibrosis
5) Subjects with the past history of severe heart disease
6) Severe Paresthesia or Sensory disorder with motor dysfunction
7) Severe pleural effusion, ascites, or pericardial effusion
8) Subjects with the past history of severe diseases (kidney disease,liver disease, heart disease).
9) History of Radiation therapy for pancrearic cancer
10) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
11) Inappropriate to be enrolled in this study judged by the investigators
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Moriyama |
Organization
Shimane University Hospital
Division name
Hematology/Oncology
Zip code
Address
89-1 Enya-cho Izumo city, Shimane Japan
TEL
0853-23-2111
ichimori@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Moriyama |
Organization
Shimane University Hospital
Division name
Hematology/Oncology
Zip code
Address
89-1 Enya-cho Izumo city, Shimane Japan
TEL
0853-23-2111
Homepage URL
ichimori@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
AdaBio Co.
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
島根大学医学部附属病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029709
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