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Unknown

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 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

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.

Find a Location

Who is running the clinical trial?

OPIS s.r.lUNKNOWN
Galecto Biotech ABLead Sponsor
8 Previous Clinical Trials
811 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

Media Library

GB2064 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04679870 — Phase 2
Myelofibrosis Research Study Groups: GB2064
Myelofibrosis Clinical Trial 2023: GB2064 Highlights & Side Effects. Trial Name: NCT04679870 — Phase 2
GB2064 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04679870 — Phase 2
Myelofibrosis Patient Testimony for trial: Trial Name: NCT04679870 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any slots available to join this experiment?

"Correct. Records on clinicaltrials.gov indicate that this research is currently recruiting volunteers, with the trial having been published on June 9th 2021 and revised November 23rd 2022. The study requires 21 participants from a single centre."

Answered by AI

How many participants have committed to the trial thus far?

"Absolutely. According to the data hosted on clinicaltrials.gov, this medical trial was posted on June 9th 2021 and last updated November 23rd 2022. The study is recruiting 21 individuals from a single site."

Answered by AI

Does the FDA sanction the use of GB2064?

"Thanks to prior data that demonstrates its safety profile, GB2064 was graded a 2. However, there is currently no clinical evidence supporting the efficacy of this medication."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Universitätsklinikum Heidelberg
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
Colorado
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have primary myelo fibrosis.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosis
2021. "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04679870.
All > Myelofibrosis
~5 spots leftby Apr 2025
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