← Back to Search

Other

GSK4524101 + Niraparib for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant has histologically diagnosed advanced or metastatic solid tumor and has exhausted all standard of care treatment options.

More than or equal to (≥)18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 52 weeks

Awards & highlights

Study Summary

This trial tests a new drug & its combination to find the maximum dose that's tolerated by patients. It has two parts to determine the dose.

Who is the study for?

Adults (18+) with advanced or metastatic solid tumors who have no remaining standard treatment options can join. They should be fairly active and mobile (ECOG 0-2) and expected to live at least 3 more months. People are excluded if they haven't recovered from previous chemo side effects, have certain types of breast cancer, used PARP inhibitors, or have specific blood cancers, uncontrolled high blood pressure, or untreated brain metastases.Check my eligibility

What is being tested?

The trial is testing GSK4524101 alone and combined with Niraparib to find the highest dose patients can tolerate without severe side effects. It's in two stages: first finding the right doses (Dose Escalation), then giving those doses to more people to see how well they work (Dose Expansion).See study design

What are the potential side effects?

Possible side effects include typical reactions related to chemotherapy such as nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Specific risks may also involve issues due to drug interactions between GSK4524101 and Niraparib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have an advanced cancer and no standard treatments are left.

Select...

I am 18 years old or older.

Select...

I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 52 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period

Part 1 - Number of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period

Part 1 - Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period

+3 more

Secondary outcome measures

Part 1 - Area Under Curve (AUC) of GSK4364973 (Metabolite of GSK4524101)

Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period

Part 1 - Half-life of GSK4364973 (Metabolite of GSK4524101) (Days)

+11 more

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Part 2 - GSK4524101 plus NiraparibExperimental Treatment2 Interventions

Group II: Part 1 - GSK4524101 plus NiraparibExperimental Treatment2 Interventions

Group III: Part 1 - GSK4524101 MonotherapyExperimental Treatment1 Intervention

Group IV: Part 1 - GSK4524101 Food Effect CohortExperimental Treatment1 Intervention

Group V: Part 2 - NiraparibActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~1540

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,700 Total Patients Enrolled

5 Trials studying Tumors

1,919 Patients Enrolled for Tumors

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,805 Total Patients Enrolled

1 Trials studying Tumors

12 Patients Enrolled for Tumors

Frequently Asked Questions

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

Are there numerous venues within this state that are presently executing the trial?

"At the moment, 6 different clinical centres are recruiting participants for this trial. San Francisco, Saint Louis and Dallas are three of these locations - amongst a few others - with selecting your closest clinic being essential to minimise travel needs if you choose to join."

Answered by AI

Are contemporary participants still being welcomed into this research?

"Clinicaltrials.gov reports that this medical experiment is no longer searching for participants, as the trial was first announced on November 9th 2023 and last edited October 5th 2023. Fortunately there are 2,542 other trials currently open to patients seeking treatment options."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors

2023. "A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06077877.

All > Cancer > Oncology