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Nintedanib and paclitaxel in BRAF wildtype metastatic melanoma
NCT02308553Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2015
- Primary completion
- Oct 2019
- Countries
- 1
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Conditions
- Cutaneous malignant melanoma
01
Overview
Phase 2, randomised, double-blind trial of nintedanib intravenous solution in Cutaneous malignant melanoma (2 arms). Primary endpoint: Progression-Free Survival at 12 months. Started Mar 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nintedanib + Paclitaxel
Experimental arm receiving nintedanib in combination with paclitaxel followed by nintedanib monotherapy.
Nintedanib-Placebo + Paclitaxel
Control arm receiving placebo in combination with paclitaxel followed by placebo monotherapy.
03
Who it enrols
Patients with histologically confirmed BRAF V600 wildtype metastatic cutaneous malignant melanoma, ECOG 0-1, and no prior treatment with taxanes or kinase inhibitors.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Overall Survival
Safety and toxicity
Quality of Life
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