Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.
The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
Samyang Biopharmaceuticals
Seoul, South Korea
RECRUITINGObjective response rate (ORR) as assessed by RECIST.
ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines. Response is confirmed at least 4 weeks later.
Time frame: 8 weeks
Progression free survival (PFS)
Time from the date of enrollment until the date of objective disease progression or the date of death. PFS will be summarized using Kaplan-Meier methods.
Time frame: 2 years
Overall survival (OS)
OS will be summarized using Kaplan-Meier methods.
Time frame: 2 years
Disease control rate (DCR)
DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time frame: 8 weeks
Number of participants with adverse events
A adverse event (AE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 21 days after the last dose of the last study drug. Severity grades according to NCI CTCAE version 4.0.
Time frame: Baseline up to Day 21 after the last dose of study treatment
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