Locally advanced pancreatic cancer MedDRA version: 17.1 Level: LLT Classification code 10033606 Term: Pancreatic cancer non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Abraxane
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Current Sponsor code: ABI-007
Concentration unit: mg milligram(s)
C
Sponsors
Celgene Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 plus gemcitabine -To evaluate the overall response rate (ORR) -To evaluate the overall progression-free survival (PFS) and overall survival (OS) -To assess the overall safety profile -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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: 1. DCR after 6 cycles of nab-paclitaxel plus gemcitabine 2. ORR 3. PFS 4. OS 5. differences in outcomes from baseline Secondary safety endpoint: - incidence of treatment-emergent AEs, SAEs, laboratory abnormalities and other safety parameters;Timepoint(s) of evaluation of this end point: Secondary efficacy endpoints: 1. defined as the combined incidence of complete response, partial response and stable disease measured at the End of Treatment visit 2. defined as the combined incidence of CR and PR 3. defined as the time after the first dose of study therapy to disease progression or death (by any cause) 4. defined as the time after the first dose of study therapy to death (by any cause) 5. during treatment, and after treatment with nab-paclitaxel plus gemcitabine for the EORTC quality of life questionnaires, EORTC QLQC30 and QLQ-PAN26 Secondary safety endpoint: - After signing ICF and until 28 days after the last dose of IP or 28-day Followup Visit, whichever occurs later. Not during survival unless it is a suspected SAE. | — |
Countries
Canada, France, Italy, Spain, United States
Contacts
Public ContactClinicalTrialDisclosure
Celgene Corporation
Outcome results
None listed