HDAC Inhibitor Vorinostat in Resistant BRAF V600 Mutated Advanced Melanoma

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02836548
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    vorinostat 360 milligram once daily

Study Details

This is a mono-center open-label proof-of-concept pharmacologic study to explore the efficacy and safety of vorinostat in advanced BRAF mutated melanoma, which became resistant for BRAF-inhibitors or the combination of BRAF- and MEK-inhibitors.

Key Dates

Start date
Jun 30, 2016
Status verified
Oct 2018
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: vorinostat
    Vorinostat 360 mg once daily

Primary Outcome Measure

Anti-tumor response rate in at least 30% of the treated patients. [ Time Frame: CT scan every 6 weeks up to 24 months and monthly phone call until start of subsequent anticancer therapy or until all patients have been followed up for at least 24 months or have been lost to follow up, whichever occurs first. ]

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