JPRN-jRCTs061180074
Recruiting
Phase 1
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)
FUKUBA Nobuhiko0 sites35 target enrollmentMarch 20, 2019
Conditionspancreatic cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- pancreatic cancer
- Sponsor
- FUKUBA Nobuhiko
- Enrollment
- 35
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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