Safety and Efficacy for Gemcitabine plus nab-paclitaxel with MK615 combination therapy in unresected/recurrent metastatic pancreatic cancer.: Phase I/II study (PC(UR-M) GEM/nab-PTX + MK615)

JRCT ID: jRCTs061180074

Registered date:20/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 30/05/2018
• Target sample size: 35
• Study type: Interventional

Intervention(s)

Gemcitabine plus nab-paclitaxel with MK615 combination therapy

Gemcitabine
1000 mg/m2 IV one time over 30 minutes.
Weekly dosing on Days 1, 8, and 15 of 28 day cycles.

nab-paclitaxel
125 mg/m2 IV one time over 30 minutes.
Weekly dosing on Days 1, 8, and 15 of 28 day cycles.

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 r.

Outcome(s)

Primary Outcome

Phase 1: Safety (Adverse Event)
Phase 2: Disease Control Rate

Secondary Outcome

Phase 1: Response Rate, Disease Control Rate, Overall survival, Progression Free Survival, Time to Treatment Failure
Phase 2: Response Rate, Overall survival, Progression Free Survival, Time to Treatment Failure, Safety (Adverse Event)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

(1)Histopathologically confirmed pancreatic cancer (adenocarcinoma and
adenosquamous carcinoma)
(2)Not resectable metastatic pancreatic cancer
(3)With measurable lesions by RECIST ver 1.1
(4)No prior chemo-, immune-, radiotherapy
(5)ECOG performance status of 0 or 1
(6)20-80 years old
(7)Expected survival period is more than 3 months
(8)The organ function must be kept within 14 days before registration
leukocyte >= 3,000/mcL , neutrophil >=1,500/mcL , platelet >=75,000/mcL, hemoglobin >=10.0 g/dL, T-Bilirubin >=2.0 mg/dL, AST =<100 IU/L (AST = <300 IU/L with liver metastasis or biliary drainage), ALT =<100 IU/L (ALT =<300 I U/L with liver metastasis or biliary drainage), serum creatinine =<1.5 mg/dL
(9)written informed consent got from the patient

Exclude 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 pancreatic 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

Related Information

• Primary Sponsor: FUKUBA Nobuhiko
• Source(s) of Monetary Support: AdaBio Co., Ltd
• Secondary ID(s): UMIN000035158