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Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma

NCT02117362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-03-21

No results posted yet for this study

Summary

The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is a galectin. Galectins are a family of proteins that have numerous functions in normal mammalian biology including the facilitation of cell-cell interactions, regulation of cell-death and regulation of immune system responses. The hypothesis is that a safe dose of GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.

Conditions

Interventions

BIOLOGICAL

1 mg/kg GR-MD-02

1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.

BIOLOGICAL

2 mg/kg GR-MD-02

2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.

BIOLOGICAL

4 mg/kg GR-MD-02

4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65

BIOLOGICAL

8 mg/kg GR-MD-02

8 mg/mg GR-MD-02

BIOLOGICAL

Ipilimumab

3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Sponsors & Collaborators

  • Providence Health & Services

    lead OTHER

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER

  • Galectin Therapeutics Inc.

    collaborator INDUSTRY

Principal Investigators

  • Brendan Curti, MD · Providence Health & Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-08
Primary Completion
2018-11-28
Completion
2018-11-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02117362 on ClinicalTrials.gov