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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02117362
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : March 21, 2019
Sponsor:
Collaborators:
Providence Cancer Center, Earle A. Chiles Research Institute
Galectin Therapeutics Inc.
Information provided by (Responsible Party):
Providence Health & Services

Tracking Information
First Submitted Date  ICMJE April 14, 2014
First Posted Date  ICMJE April 17, 2014
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE May 8, 2014
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg) [ Time Frame: 21 Days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2014)
Response rate to combined therapy [ Time Frame: 85 Days ]
Tumor burden assessments will occur at screening, Day 85, and every 12 weeks thereafter to determine the response rate.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
Official Title  ICMJE Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
Brief 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.
Detailed Description This study will employ a 3+3 phase I design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Melanoma
Intervention  ICMJE
  • Biological: 1 mg/kg GR-MD-02
    1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
    Other Names:
    • galectin-3 inhibitor
    • galactoarabino-rhamnogalacturonate
  • Biological: 2 mg/kg GR-MD-02
    2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
    Other Names:
    • galectin-3 inhibitor
    • galactoarabino-rhamnogalacturonate
  • Biological: 4 mg/kg GR-MD-02
    4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
    Other Names:
    • galectin-3 inhibitor
    • galactoarabino-rhamnogalacturonate
  • Biological: 8 mg/kg GR-MD-02
    8 mg/mg GR-MD-02
    Other Names:
    • galectin-3 inhibitor
    • galactoarabino-rhamnogalacturonate
  • Biological: Ipilimumab
    3 mg/kg ipilimumab on Days 1, 22, 43, and 65
    Other Names:
    • Yervoy
    • Anti-CTLA 4
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: 1 mg/kg GR-MD-02
    • Biological: Ipilimumab
  • 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.
    Interventions:
    • Biological: 2 mg/kg GR-MD-02
    • Biological: Ipilimumab
  • 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.
    Interventions:
    • Biological: 4 mg/kg GR-MD-02
    • Biological: Ipilimumab
  • 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.
    Interventions:
    • Biological: 8 mg/kg GR-MD-02
    • Biological: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2018)
8
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2014)
22
Actual Study Completion Date  ICMJE November 28, 2018
Actual Primary Completion Date November 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with metastatic or unresectable melanoma for whom treatment with ipilimumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology.
  • Patients must be ≥ 18 years of age.
  • Eastern Collaborative Oncology Group (ECOG) performance status of 0-1.
  • Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
  • No active bleeding.
  • Anticipated lifespan greater than 12 weeks.
  • Patients must sign a study-specific consent document.

Exclusion Criteria:

  • Patients who have previously received a galectin antagonist
  • Prior ipilimumab to treat metastatic melanoma (prior ipilimumab in the adjuvant setting is permitted if the patient did not experience ≥ grade 3 toxicity related to immunotherapy.
  • Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.
  • Patients with history of colitis
  • Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible.
  • Other active metastatic cancer requiring treatment.
  • Patients with active infection requiring antibiotics.
  • Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
  • Laboratory exclusions (to be performed within 28 days of enrollment):
  • Need for chronic steroids. Inhaled corticosteroids are acceptable.
  • Inability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
  • Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02117362
Other Study ID Numbers  ICMJE 14-004A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Providence Health & Services
Study Sponsor  ICMJE Providence Health & Services
Collaborators  ICMJE
  • Providence Cancer Center, Earle A. Chiles Research Institute
  • Galectin Therapeutics Inc.
Investigators  ICMJE
Principal Investigator: Brendan Curti, MD Providence Health & Services
PRS Account Providence Health & Services
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP