UMIN-CTR Clinical Trial

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