Ignite Creation Date:
2024-05-06 @ 3:31 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02308553
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2014-12-02
Brief Title:
Efficacy and Safety of Nintedanib Combined With Paclitaxel Chemotherapy for Patients With BRAF wt Metastatic Melanoma
Sponsor:
Prof Dr med Dirk Schadendorf
Organization:
University Hospital Essen
Study Overview
Official Title:
Phase IIIMulticenterRandomizedDouble-blindPlacebo-controlled Trial Evaluating the Efficacy and Safety of NintedanibVargatef in Combination With Paclitaxel Chemotherapy for Treatment of Patients With BRAF Wildtype Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIPAWILMA
Brief Summary:
This is a multicenter randomized double-blind placebo-controlled phase III 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
Detailed Description:
Study Phase I Run-In-Phase Based on acceptable safety data for nintedanib monotherapy a rapid dose finding will be conducted in a classical 33 design Predefined dose levels are 150 mg dose level 1 and 200 mg dose level 2 nintedanib twice daily with weekly paclitaxel 90 mgm2
Study Phase II Patients with advanced unresectable Stage III or IV BRaf V600 wild type melanoma n120 will be randomized 11 to receive either Nintedanib 150 or 200 mg BID depending on results of phase I in combination with paclitaxel or Placebo in combination with paclitaxel
Total study duration per patient approximately 12 months of therapy Follow up until end of study
All patients enrolled in either phase I or phase II will be treated according to the following treatment plan
Week 1 - 24
Chemotherapy with paclitaxel combined with nintedanibplacebo
Week 25 - 48
Extended monotherapy with nintedanibplacebo
Week 52 or approximately 4 weeks after last treatment dose
End of Treatment visit
Follow up
After end of treatment the survival disease status and further therapies of each patient will be assessed every 3 months until death progression of disease or end of study whichever occurs first
Study Phase II Patients with advanced unresectable Stage III or IV BRaf V600 wild type melanoma n120 will be randomized 11 to receive either Nintedanib 150 or 200 mg BID depending on results of phase I in combination with paclitaxel or Placebo in combination with paclitaxel
Total study duration per patient approximately 12 months of therapy Follow up until end of study
All patients enrolled in either phase I or phase II will be treated according to the following treatment plan
Week 1 - 24
Chemotherapy with paclitaxel combined with nintedanibplacebo
Week 25 - 48
Extended monotherapy with nintedanibplacebo
Week 52 or approximately 4 weeks after last treatment dose
End of Treatment visit
Follow up
After end of treatment the survival disease status and further therapies of each patient will be assessed every 3 months until death progression of disease or end of study whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None