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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035158
Receipt No. R000040070
Official scientific title of the study Safety and Efficacy for Gemcitabine plus nab-paclitaxel with MK615 combination therapy in unresected/recurrent metastatic pancreatic cancer.: Phase I/II study
Date of disclosure of the study information 2018/12/06
Last modified on 2018/12/06

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Basic information
Official scientific title of the study Safety and Efficacy for Gemcitabine plus nab-paclitaxel with MK615 combination therapy in unresected/recurrent metastatic pancreatic cancer.: Phase I/II study
Title of the study (Brief title) PC(UR-M) GEM/nab-PTX + MK615
Region
Japan

Condition
Condition unresected/recurrent metastatic pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I: Safety and tolerability
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: Tolerability of MK615 within 8 weeks
Phase II: Response rate
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 Historical
Stratification NO
Dynamic allocation NO
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.

nab-paclitaxel
125 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.

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).Phase I: Taking 3 packages of MK615 daily in 1 course. Taking 6 packages of MK615 daily from after 1 course.
Phase II: Taking 6 packages of MK615 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
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Histopathologically confirmed pancreatic cancer(adenocarcinoma and adenosquamous carcinoma)
(2) unresected/recurrent metastatic pancreatic cancer
(3) Have measurable lesions by RECIST ver1.1
(4) No prior systemic chemotherapy, immunotherapy or radiotherapy ( Adjuvant chemotherapy was allowed)
(5) ECOG performance status of 0, 1 or 2
(6) 20<= years old, <80 years old.
(7) Expected survival period is more than 3 months
(8) The organ function must be kept within 14 days before registration
8-1 leukocyte >= 3,000/mcL
8-2 neutrophil >=1,500/mcL
8-3 platelet >=75,000/mcL
8-4 hemoglobin >=10.0 g/dL.
8-5 T-Bilirubin >=2.0 mg/dL
8-6 AST =<100 IU/L (AST =<300 IU/L with liver metastasis)
8-7 ALT =<100 IU/L (ALT =<300 IU/L with liver metastasis)
8-8 serum creatinine =<1.5 mg/dL
(9) 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) Symptomatic brain metastases or Clinically suspected brain metastases.
(11) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test
(12) Inappropriate to be enrolled in this study judged by the investigators
Target sample size 31

Research contact person
Name of lead principal investigator Junji Suzumiya
Organization Shimane University Hospital
Division name Oncology/Hematology
Address 89-1, Enya-cho, Izumo, Shimane
TEL 0853-23-2111
Email suzumiya@med.shimane-u.ac.jp

Public contact
Name of contact person Ichiro Moriyama
Organization Shimane University Hospital
Division name Oncology/Hematology
Address 89-1, Enya-cho, Izumo, Shimane
TEL 0853-23-2111
Homepage URL
Email ichimori@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Hospital
Institute
Department

Funding Source
Organization AdaBio Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 06 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 05 Month 28 Day
Anticipated trial start date
2018 Year 05 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 12 Month 06 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=R000040070

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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