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

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT02117362
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 1 mg/kg GR-MD-02 — BIOLOGICAL
    1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
  • 2 mg/kg GR-MD-02 — BIOLOGICAL
    2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
  • 4 mg/kg GR-MD-02 — BIOLOGICAL
    4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
  • 8 mg/kg GR-MD-02 — BIOLOGICAL
    8 mg/mg GR-MD-02
  • Ipilimumab — BIOLOGICAL
    3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Study Details

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.

Key Dates

First listed
Apr 17, 2014
Start date
May 8, 2014
Status verified
Apr 2018
Primary completion
Nov 28, 2018
Completion
Nov 28, 2018

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
  • Experimental: Cohort 2
    2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
  • Experimental: Cohort 3
    4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
  • Experimental: Cohort 4
    8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.

Primary Outcome Measure

Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg) [ Time Frame: 21 Days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Medical CenterPortlandOregon97213-

Find similar trials in Portland, OR

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By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Providence Portland Medical Center· Portland, OR

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