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GS-3583 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by Gilead Sciences

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 cycle 1 through cycle 13 (each cycle is 28 days) and up to 60-day follow-up visit (60 days after last dose date) or end of treatment (up to 52 weeks)

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and how well it works in people with advanced solid tumors.

Eligible Conditions

Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 through cycle 13 (each cycle is 28 days) and up to 60-day follow-up visit (60 days after last dose date) or end of treatment (up to 52 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 through cycle 13 (each cycle is 28 days) and up to 60-day follow-up visit (60 days after last dose date) or end of treatment (up to 52 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 through cycle 13 (each cycle is 28 days) and up to 60-day follow-up visit (60 days after last dose date) or end of treatment (up to 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

Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

Percentage of Participants Experiencing Lab Abnormalities According to the NCI CTCAE Version 5.0

Secondary outcome measures

Pharmacokinetic (PK) Parameter: AUCtau of GS-3583

Trial Design

1Treatment groups

Experimental Treatment

Group I: GS-3583 Dose EscalationExperimental Treatment1 Intervention

Participants will receive an escalating dose of GS-3583 for up to 52 weeks or until the participant meets study treatment discontinuation criteria.

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Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

843,466 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,680 Total Patients Enrolled

Frequently Asked Questions

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

Has GS-3583 been granted endorsement by the FDA?

"Currently, GS-3583's safety has been given a score of 1 due to the fact that this is still in its first stage of clinical trials and there are only limited data on both efficacy and safety."

Answered by AI

How many North American sites are currently executing this research endeavor?

"In addition to START Midwest in Grand Rapids, Michigan and NEXT Oncology in San Antonio, Texas; the Icahn School of Medicine at Mount Sinai in New york City is also partaking as a research centre for this clinical trial."

Answered by AI

Are there any enrolment opportunities available for this experiment?

"Unfortunately, according to clinicaltrials.gov, this medical experiment which was initially put up on March 25th 2021 is not currently recruiting patients for participation. In spite of that, there are 2,502 other studies actively looking for volunteers right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors

2021. "Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583 in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04747470.