Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma

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Uveal melanoma
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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