Brief Title
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Official Title
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
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
Occurrence of Adverse Events
Secondary Outcome
Changes in Plasma Levels of ICON-1.
Condition
Uveal Melanoma
Intervention
ICON-1
Study Arms / Comparison Groups
ICON-1 0.3 mg Singe Dose
Description: Patients will receive a single intravitreal dose of ICON-1 0.3 mg
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
10
Start Date
May 2016
Completion Date
September 2017
Primary Completion Date
September 2017
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gabriela Burian, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02771340
Organization ID
IT-003
Responsible Party
Sponsor
Study Sponsor
Iconic Therapeutics, Inc.
Study Sponsor
Gabriela Burian, MD, Study Director, Iconic Therapeutics, Inc.
Verification Date
September 2020