TRIAL OF ABRAXANE AND GEMCITABINE TO TREATMENT PANCREATIC CANCER PATIENTS WHO CAN NOT HAVE SURGERY BECAUSE OF CANCER LOCATIO

Phase 1

Conditions: ocally advanced pancreatic cancer
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 17.1Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864

Registration Number: EUCTR2014-001408-23-ES

Lead Sponsor: Celgene Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

?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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 77

Exclusion Criteria

?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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the time to treatment failure in LAPC subjects treated with nab-paclitaxel plus gemcitabine as induction therapy followed by Investigator?s Choice of treatment;Secondary Objective: -To evaluate the disease control rate (DCR) after the first 6 cycles of nab-paclitaxel<br>plus gemcitabine<br>-To evaluate the overall response rate (ORR)<br>-To evaluate the overall progression-free survival (PFS) and overall survival (OS)<br>-To assess the overall safety profile<br>-To evaluate the subject?s health-related quality of life (QoL);Primary end point(s): Time to treatment failure;Timepoint(s) of evaluation of this end point: Time after the first dose of study therapy to treatment failure

Secondary Outcome Measures