2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

151

Participants

Timeline

Start Date

March 31, 2018

Primary Completion Date

May 31, 2022

Study Completion Date

May 31, 2022

Conditions
Locally Advanced Pancreatic CancerMetastatic Pancreatic Cancer
Interventions
DRUG

Irinotecan Liposomal Injection [Onivyde]

"Cancer treatment for PDAC:~* Nal-IRI (4.3 mg/ml) 70 mg/m2 as 1.5 hour infusion~* 5-FU 2400 mg/m2 as 46 hour infusion~* Folinic acid 400 mg/m2 as 0.5 hour infusion~* all on D1 of each cycle; Cycle q2w ± 5 days~Treatment until progressive disease or intolerable toxicity or withdrawal of consent."

Trial Locations (35)

14770

Städtisches Klinikum Brandenburg, Brandenburg

15526

HELIOS Klinikum Bad Saarow, Bad Saarow

18059

Klinikum Südstadt Rostock, Rostock

26121

Pius-Hospital, Oldenburg

26655

Medizinische Studiengesellschaft Onkologie Nord-West GmbH, Westerstede

30171

Medi Projekt, Hanover

34121

DRK-Kliniken Nordhessen, Kassel

35043

Uniklinikum Marburg, Marburg

38642

MVZ Onkologische Kooperation Harz, Goslar

44791

St.Josef-Hospital Klinikum der Ruhr-Universität Bochum, Bochum

50935

St. Elisabeth-Krankenhaus GmbH, Köln - Hohenlind

50937

Uniklinikum Köln GmbH, Cologne

52146

Hämatologisch-Onkologische Praxis Würselen, Würselen

65189

St. Josefs-Hospital, Wiesbaden

65812

Hämatologisch-Onkologische Gemeinschaftspraxis, Bad Soden

66113

Caritas-Klinik St. Theresia, Saarbrücken

66421

Universitätsklinikum des Saarlandes, Homburg

67063

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen

68167

Universitätsmedizin Mannheim, Mannheim

74523

Diakonie Klinikum gGmbH, Schwäbisch Hall

77654

Ambulantes Therapiezentrum Hämatologie / Onkologie, Offenburg

78052

Schwarzwald-Baar-Klinikum, Villingen-Schwenningen

81737

Krankenhaus Neuperlach, München

84034

Klinikum Landshut gGmbH, Landshut

88212

Studienzentrum Onkologie Ravensburg, Ravensburg

89081

Universitätsklinikum Ulm, Ulm

90419

Klinikum Nürnberg Nord, Nuremberg

92224

Klinikum St. Marien Amberg, Amberg

92637

Kliniken Nordoberpfalz Klinikum Weiden, Weiden

94469

Donauisar Klinikum, Deggendorf

96450

MVZ Klinikum Coburg GmbH, Coburg

97422

Leopoldina Krankenhaus, Schweinfurt

01307

BAG Onkologische Gemeinschaftspraxis Dresden, Dresden

04289

Onkopraxis Probstheida, Leipzig

01589

Elblandklinikum Riesa, Riesa

All Listed Sponsors
collaborator

Crolll Gmbh

OTHER

collaborator

Servier Deutschland GmbH

INDUSTRY

lead

AIO-Studien-gGmbH

OTHER

NCT03468335 - 2nd-line Therapy With Nal-IRI After Gem/Nab-pac in Advanced Pancreatic Cancer - Predictive Role of 1st-line Therapy | Biotech Hunter | Biotech Hunter