NCT02032810

Phase I of Histone Deacetylase (HDAC) Inhibitor Panobinostat With Ipilimumab With Unresectable III/IV Melanoma

A Phase 1 Study of HDAC Inhibitor Panobinostat (LBH 589) Administered in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if an investigational drug called panobinostat can be given safely with another drug called ipilimumab. Investigators want to learn more about the side effects of this combination of drugs using different doses of panobinostat and the same dose of ipilimumab.

Conditions

• Melanoma
• Skin Cancer

Interventions

Type	Name	Description
DRUG	Panobinostat	Participants will be assigned to receive a certain dose of panobinostat (5, 10, 15, or 20 mg). The dose of panobinostat will depend on the time point the participant enters the study and the side effects of other participants already on the study.
DRUG	Ipilimumab	Dose of ipilimumab of 3 mg per kg (mg/kg) of body weight.

Timeline

• Start date: 2014-01-07
• Primary completion: 2017-09-06
• Completion: 2019-09-25
• First posted: 2014-01-10
• Last updated: 2023-01-20
• Results posted: 2019-07-02

Locations

1 site across 1 country: United States