Status:
COMPLETED
Phase 2 Nab® -Paclitaxel (Abraxane®) Plus Gemcitabine in Subjects With Locally Advanced Pancreatic Cancer (LAPC)
Lead Sponsor:
Celgene
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical study is in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatment for their pancreatic cancer. The study treats all subject...
Detailed Description
This is an international, non-randomized, open-label, multi-center, Phase 2 study in subjects who are 18 years old or older with locally advanced pancreatic cancer who have not received prior treatmen...
Eligibility Criteria
Inclusion
- Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
- No prior anticancer therapy for pancreatic cancer
- •≥ 18 years of age with a performance status of 0 or 1•Adequate complete blood counts, hepatic function, and renal function
- Signed informed Consent
Exclusion
- Active bacterial, viral, or fungal infection
- Infection with hepatitis B or C, or history of human immunodeficiency virus (HIV) infection, or receiving immunosuppressive or myelosuppressive
- Subjects with sensory neuropathy, ascites, or plastic biliary stent.
- Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders (including but not limited to connective tissue disorders, lung disease, and cardiac or seizure disorders)
- Women who are pregnant or breast feeding
Key Trial Info
Start Date :
April 21 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 26 2018
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT02301143
Start Date
April 21 2015
End Date
April 26 2018
Last Update
March 20 2019
Active Locations (42)
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1
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
2
UC Davis Cancer Center
Sacramento, California, United States, 95817
3
Scripps Clinic Torrey Pines
San Diego, California, United States, 92037
4
Smilow Cancer Hospital At Yale-New Haven
New Haven, Connecticut, United States, 06510