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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025844
Receipt No. 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

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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
Email 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
Email ichimori@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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