Safety and Efficacy for Gemcitabine plus nab-paclitaxel with MK615 combination therapy in unresected/recurrent metastatic pancreatic cancer.: Phase I/II study
- Conditions
- unresected/recurrent metastatic pancreatic cancer
- Registration Number
- JPRN-UMIN000035158
- Lead Sponsor
- Shimane University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 31
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Tolerability of MK615 within 8 weeks Phase II: Response rate
- Secondary Outcome Measures
Name Time Method