UMIN-CTR Clinical Trial

Public title

Safety and Efficacy for Gemcitabine plus nab-paclitaxel with MK615 combination therapy in unresected/recurrent metastatic pancreatic cancer.: Phase I/II study

Acronym

PC(UR-M) GEM/nab-PTX + MK615

Scientific Title

Safety and Efficacy for Gemcitabine plus nab-paclitaxel with MK615 combination therapy in unresected/recurrent metastatic pancreatic cancer.: Phase I/II study

Scientific Title:Acronym

PC(UR-M) GEM/nab-PTX + MK615

Region

Japan

Condition

unresected/recurrent metastatic pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Phase I: Safety and tolerability

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Phase I: Tolerability of MK615 within 8 weeks
Phase II: Response rate

Key secondary outcomes

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Junji Suzumiya

Organization

Shimane University Hospital

Division name

Oncology/Hematology

Zip code

Address

89-1, Enya-cho, Izumo, Shimane

TEL

0853-23-2111

Email

suzumiya@med.shimane-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Ichiro Moriyama

Organization

Shimane University Hospital

Division name

Oncology/Hematology

Zip code

Address

89-1, Enya-cho, Izumo, Shimane

TEL

0853-23-2111

Homepage URL

Email

ichimori@med.shimane-u.ac.jp

Institute

Shimane University Hospital

Institute

Department

Personal name

Organization

AdaBio Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

島根大学医学部附属病院

Date of disclosure of the study information

2018

Year

12

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

05

Month

28

Day

Date of IRB

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

Other related information

Registered date

2018

Year

12

Month

06

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=R000040070