325
Participants
Start Date
December 31, 2016
Primary Completion Date
March 31, 2022
Study Completion Date
May 31, 2022
nab-paclitaxel and gemcitabine
"Induction treatment:~3 cycles nab-paclitaxel and gemcitabine 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.~Continouous treatment after randomization:~Continuing application of nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity. Duration of each cycle is 28 days nab-paclitaxel 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle."
gemcitabine mono and nab-paclitaxel and gemcitabine
"Induction treatment:~3 cycles nab-paclitaxel and gemcitabine 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.~Continouous treatment after randomization:~Alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity, starting with a treatment cycle of gemcitabine monotherapy.~Duration of each cycle irrespective of treatment cycle with gemcitabine monotherapy or treatment with nab-paclitaxel/gemcitabine is 28 days.~Gemcitabine monotherapy treatment cycle: Gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.~Nab-paclitaxel and gemcitabine treatment cycle: Nab-paclitaxel 125 mg/m\^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m\^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle."
Kliniken Nordoberpfalz AG, Klinikum Weiden, Weiden
Collaborators (2)
ClinAssess GmbH
INDUSTRY
Celgene Corporation
INDUSTRY
AIO-Studien-gGmbH
OTHER