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

NCT02308553 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-10-14

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase I/II trial designed to characterize the safety and estimate the efficacy of nintedanib when combined with paclitaxel chemotherapy compared with paclitaxel chemotherapy alone in patients with BRAF wild type metastatic melanoma not previously treated with taxanes or kinase inhibitors.

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)

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • medac GmbH

    collaborator INDUSTRY

  • Alcedis GmbH

    collaborator INDUSTRY

  • Prof. Dr. med. Dirk Schadendorf

    lead OTHER

Principal Investigators

  • Dirk Schadendorf, Prof. Dr. · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-17
Primary Completion
2019-10-17
Completion
2019-11-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308553 on ClinicalTrials.gov