Atu027 Plus Gemcitabine in Advanced or Metastatic Pancreatic Cancer (Atu027-I-02)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

January 31, 2016

Conditions
Carcinoma, Pancreatic Ductal
Interventions
DRUG

Atu027 & gemcitabine in lead in safety period

Subjects will be treated in a 28-day cycle with Atu027 twice weekly for 4 weeks and gemcitabine once weekly for the first three weeks.

DRUG

Atu027 & gemcitabine in treatment arm 1

"Subjects will be treated in a 28-day cycle with Atu027 and gemcitabine once weekly for three consecutive weeks (on days 1, 8, and 15). During week four no treatment is administered.~Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs."

DRUG

Atu027 & gemcitabine in treatment arm 2

"Subjects will be treated in a 28-day cycle with gemcitabine once weekly (on days 4, 11, and 18) and Atu027 twice weekly (on days 1, 4, 8, 11, 15, 18, 22, and 25). The 28-day combination cycle is followed by a 28-day gemcitabine monotherapy cycle.~Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs."

Trial Locations (9)

13353

Charité - Universitätsmedizin Berlin Charité Centrum für Tumormedizin, Berlin

34125

Klinikum Kassel GmbH Medizinischen Klinik IV;Onkologie,, Kassel

44137

Klinikum Dortmund gGmbH Medizinische Klinik Mitte, Dortmund

44625

Medizinische Klinik III - Hämatologie/Onkologie Marienhospital Herne, Herne

70174

Klinikum Stuttgart Klinik Hämatologie, Onkologie und Palliativmedizin, Stuttgart

79106

Universitätsklinikum Freiburg, Innere Medizin II, Freiburg im Breisgau

89061

Universitätsklinikum Ulm Zentrum für Innere Medizin, Ulm

90419

Klinikum Nürnberg Nord Medizinische Klinik 5, Nuremberg

93042

Klinik und Poliklinik für Innere Medizin I Universitätsklinikum Regensburg, Regensburg

All Listed Sponsors
collaborator

Granzer Regulatory Consulting & Services

OTHER

collaborator

FGK Clinical Research GmbH

INDUSTRY

lead

Silence Therapeutics GmbH

INDUSTRY