NCT02771340CompletedPhase 1
A Phase 1, Open-label, Multicenter Study Evaluating the Safety and Tolerability, Biologic Activity, Pharmacodynamics, and Pharmacokinetics of Single and Repeated Escalating Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma Who Are Planned to Undergo Enucleation or Brachytherapy
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Iconic Therapeutics, Inc.
- Enrollment
- 10
- Locations
- 8
- Primary Endpoint
- Occurrence of Adverse Events
Study Overview
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, biological activity, pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo enucleation or brachytherapy of the affected eye.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males or females of any race at least 18 years of age
- •Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
- •Planned enucleation or brachytherapy of the study eye due to uveal melanoma
Exclusion Criteria
- •Uveal melanoma in the study eye originating in the anterior uveal tract (iris)
- •Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)
- •Woman who is pregnant or lactating
Outcomes
Primary Outcomes
Occurrence of Adverse Events
Time Frame: 30 days (plus or minus 5 days) after surgical procedure
Secondary Outcomes
- Changes in Plasma Levels of ICON-1.(Baseline to 1 day after last dose of ICON-1)
- Change in Best Corrected Visual Acuity (BCVA) From Baseline to End of Study(Baseline to on or 1 day prior to surgical procedure day)
Investigators
Study Sites (8)
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