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)

Phase 1

Recruiting

• Conditions: pancreatic cancer

• Registration Number: JPRN-jRCTs061180074
• Lead Sponsor: FUKUBA Nobuhiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion 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

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase 1: Safety (Adverse Event)<br>Phase 2: Disease Control Rate

Secondary Outcome Measures

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