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Oral GB2064 for Myelofibrosis
Phase 2
Waitlist Available
Led By Srdan Verstovsek, MD, PhD
Research Sponsored by Galecto Biotech AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial is testing a new drug for people with Myelofibrosis, a disorder where the bone marrow makes too many fibrous cells.
Who is the study for?
Adults over 18 with Myelofibrosis who haven't responded well to, or can't take, JAK inhibitors. They should have a low blast count in blood, be able to perform daily activities (ECOG 0-2), and have proper organ function. Women must use effective birth control or be non-childbearing; men must also agree to contraception.Check my eligibility
What is being tested?
The trial is testing GB2064, an oral medication for Myelofibrosis patients. It's an open-label phase IIa study which means everyone gets the drug and both the researchers and participants know what's being given.See study design
What are the potential side effects?
Specific side effects of GB2064 aren't listed but may include typical reactions like nausea, fatigue, liver issues based on its pharmacological class. Participants will be monitored for any adverse effects throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of GB2064: AE
Trial Design
1Treatment groups
Experimental Treatment
Group I: GB2064Experimental Treatment1 Intervention
GB2064 will be administered orally as 4 x 250 mg tablets twice a day.
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Who is running the clinical trial?
OPIS s.r.lUNKNOWN
Galecto Biotech ABLead Sponsor
8 Previous Clinical Trials
557 Total Patients Enrolled
Srdan Verstovsek, MD, PhDPrincipal InvestigatorThe University of Texas MD Anderson Cancer Center, Houston, TX
3 Previous Clinical Trials
504 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not currently taking a medication called Janus kinase (JAK) inhibitor and cannot take it due to medical reasons.Female participants may be of non-childbearing potential defined as permanently sterile or postmenopausal, or female participants considered to be of childbearing potential who agree to use highly effective birth control methods until 90 days after the follow-up visit.You have an advanced stage of a type of blood cancer called PMF or SMF, as determined by a scoring system, or you have a less advanced stage with an enlarged spleen that causes symptoms.You must be able to perform daily activities without assistance, or with only minor assistance.
Research Study Groups:
This trial has the following groups:- Group 1: GB2064
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Myelofibrosis Patient Testimony for trial: Trial Name: NCT04679870 — Phase 2
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