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NCT02117362 · ClinicalTrials.gov registry record · Phase 1
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
A Phase 1 study, sponsored by Providence Health & Services.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02117362: Completed Phase 1 study, sponsored by Providence Health & Services.
NCT02117362 is a Phase 1 study that has completed, run by Providence Health & Services. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02117362, a Phase 1 study, has completed, sponsored by Providence Health & Services.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
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.
Primary Outcome
Patients return to clinic 9 times in 85 days, receiving treatment on Days 1, 22, 43, and 65. Patients will have physical exams, blood tests, and toxicity evaluations by a research nurse during this time to identify any protocol-defined dose limiting toxicity.
Interventions
- BIOLOGICAL Ipilimumab
- BIOLOGICAL 1 mg/kg GR-MD-02
- BIOLOGICAL 2 mg/kg GR-MD-02
- BIOLOGICAL 4 mg/kg GR-MD-02
- BIOLOGICAL 8 mg/kg GR-MD-02
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2014-05-08 |
| Est. Completion | 2018-11-28 |
| Phase | Phase 1 |
What the finished NCT02117362 record still lists
NCT02117362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Ipilimumab is the first listed.
NCT02117362 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02117362 about?
NCT02117362 is a clinical study titled "Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma". 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 ...
What is the current status of trial NCT02117362?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2014-05-08. Estimated completion is 2018-11-28.
What interventions are being tested in trial NCT02117362?
The interventions under investigation include: Ipilimumab (BIOLOGICAL), 1 mg/kg GR-MD-02 (BIOLOGICAL), 2 mg/kg GR-MD-02 (BIOLOGICAL), 4 mg/kg GR-MD-02 (BIOLOGICAL), 8 mg/kg GR-MD-02 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02117362?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02117362's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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