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Unknown

GDC-8264 for Acute Graft-Versus-Host Disease

Phase 1

Waitlist Available

Research Sponsored by Genentech, Inc.

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 screening up to end of study (up to approximately 3 years)

Awards & highlights

Study Summary

This trial tests a drug to see if it's safe and effective to treat aGVHD, a complication of bone marrow transplants.

Who is the study for?

This trial is for individuals who have acute graft-versus-host disease (aGVHD) after a stem cell transplant. They must show signs of the disease, have had successful engraftment, and be at high risk per specific criteria. Participants should be starting treatment with systemic corticosteroids but not have received other treatments for aGVHD or more than one transplant.Check my eligibility

What is being tested?

The study tests GDC-8264's safety and how it moves through the body when given with standard care to those with aGVHD. It aims to understand if this drug can help manage symptoms safely alongside usual treatments like steroids.See study design

What are the potential side effects?

While specific side effects of GDC-8264 are not listed here, similar drugs may cause immune system suppression leading to infections, potential liver or kidney issues, allergic reactions, or gastrointestinal problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening up to end of study (up to approximately 3 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening up to end of study (up to approximately 3 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to end of study (up to approximately 3 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of Participants with At Least One Adverse Events (AEs) and As per Severity of AEs

Plasma Concentration of GDC-8264

Secondary outcome measures

Duration of Response (DOR)

Overall Response Rate (ORR)

Percentage of Participants with Non-relapse Mortality (NRM)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: GDC-8264, 75 mgExperimental Treatment1 Intervention

Participants will receive oral GDC-8264, 75 mg, PO, QD for 28 days.

Group II: GDC-8264, 35 mgExperimental Treatment1 Intervention

Participants will receive oral GDC-8264, 35 milligrams (mg), once daily (QD) for 28 days.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,539 Previous Clinical Trials

567,682 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,495 Total Patients Enrolled

Media Library

GDC-8264 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05673876 — Phase 1

Graft-versus-Host Disease Research Study Groups: GDC-8264, 35 mg, GDC-8264, 75 mg

Graft-versus-Host Disease Clinical Trial 2023: GDC-8264 Highlights & Side Effects. Trial Name: NCT05673876 — Phase 1

GDC-8264 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05673876 — Phase 1

Frequently Asked Questions

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

Are new subjects being accepted for this medical experiment currently?

"According to data available on clinicaltrials.gov, the trial is still open for enrollment and was first advertised at the close of 2022. It has since been revised as recently as December 21st in that same year."

Answered by AI

Is GDC-8264, Dose 1 a safe medication for patients to take?

"A score of 1 has been assigned to GDC-8264, Dose 1 due its limited data backing safety and efficacy. This is a Phase 1 study after all."

Answered by AI

How many participants are enrolled in this investigation?

"Affirmative. As revealed on clinicaltrials.gov, the study that was first released December 30th 2022 is currently recruiting patients. 40 people are needed from a single site to take part in this research initiative."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)

2023. "A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05673876.