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

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

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

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