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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Iconic Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02771340
First received: May 6, 2016
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Uveal Melanoma
Choroid Neoplasm
Biological: ICON-1
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Iconic Therapeutics, Inc.:

Primary Outcome Measures:
  • Occurrence of adverse events [ Time Frame: 30 days (plus or minus 5 days) after surgical procedure ]

Secondary Outcome Measures:
  • Changes in plasma levels of ICON-1 [ Time Frame: 1 day after last dose of ICON-1 ]
  • Change in best corrected visual acuity (BCVA) [ Time Frame: On or 1 day prior to surgical procedure day ]

Estimated Enrollment: 10
Study Start Date: May 2016
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ICON-1 0.3 mg Singe Dose
Patients will receive a single intravitreal dose of ICON-1 0.3 mg
Biological: ICON-1
Intravitreal injection of ICON-1
Other Name: human Immuno-conjugate 1
Experimental: ICON-1 0.3 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.3 mg, one week apart
Biological: ICON-1
Intravitreal injection of ICON-1
Other Name: human Immuno-conjugate 1
Experimental: ICON-1 0.6 mg Repeat Dosing
Patients will receive two intravitreal doses of ICON-1 0.6 mg, one week apart
Biological: ICON-1
Intravitreal injection of ICON-1
Other Name: human Immuno-conjugate 1

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02771340

Contacts
Contact: Iconic Therapeutics 650-437-1000 clinicaltrials@iconictherapeutics.com

Locations
United States, California
Recruiting
San Francisco, California, United States, 94109
United States, Colorado
Recruiting
Denver, Colorado, United States, 80401
United States, Kansas
Recruiting
Leawood, Kansas, United States, 66211
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Recruiting
Grand Rapids, Michigan, United States, 49546
Recruiting
Royal Oak, Michigan, United States, 48073
United States, Oregon
Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Iconic Therapeutics, Inc.
Investigators
Study Director: Gabriela Burian, MD Iconic Therapeutics, Inc.
  More Information

Additional Information:
Responsible Party: Iconic Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02771340     History of Changes
Other Study ID Numbers: IT-003
Study First Received: May 6, 2016
Last Updated: January 3, 2017

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Choroid Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Choroid Diseases
Immunoconjugates
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017