Efficacy and Safety of Nintedanib Combined With Paclitaxel Chemotherapy for Patients With BRAF wt Metastatic Melanoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

March 17, 2015

Primary Completion Date

October 17, 2019

Study Completion Date

November 30, 2019

Conditions
Cutaneous Malignant Melanoma
Interventions
DRUG

Nintedanib

Nintedanib (150 mg or 200 mg BID)

DRUG

Nintedanib-Placebo

Placebo (150 mg or 200 mg BID)

DRUG

Paclitaxel

Paclitaxel as 90mg/mw infusion day 1, 8, 15 q28 (6 cycles)

Trial Locations (10)

21614

Elbeklinikum Buxtehude, Buxtehude

23538

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck

45147

University Hospital Essen, Essen

48149

University Hospital Münster, Münster

48157

Fachklinik Hornheide, Münster

66421

Universitätsklinikum des Saarlandes, Homburg

67063

Klinikum der Stadt Ludwigshafen am Rhein gGmbH, Ludwigshafen

69120

National Centre for Tumour Diseases (NCT), Heidelberg

80337

University Hospital München, München

07548

SRH Wald-Klinikum Gera, Gera

Sponsors
All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

collaborator

medac GmbH

INDUSTRY

collaborator

Alcedis GmbH

INDUSTRY

lead

Prof. Dr. med. Dirk Schadendorf

OTHER