Other

GS-9716 for Solid Tumors

Q: How many settings is this experiment supervised in?

<p>START Mountain Region in G<a href="https://www.withpower.com/clinical-trials/ra">ra</a>nd Rapids, Michigan, START San Antonio in San Antonio, Texas and START Midwest in Portland Oregon are a few centres recruiting participants for this medical research. Additionally, there are 5 other clinical sites participating.</p>

START Mountain Region, Grand Rapids, MI

GS-9716 +2 morePhase 1RecruitingResearch Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Part A: GS-9716 Monotherapy

- NSCLC

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upfirst dose date to pd or death, whichever occurs first (up to 39 months)

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Study Summary

This trial is studying the side effects of a new drug called GS-9716 when given alone or with other drugs to treat patients with solid tumors that have spread to other parts of the body.

Eligible Conditions

Solid Tumors

Eligibility Criteria

Inclusion Criteria

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

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You are participating in the study to receive GS-9716 medication alone.

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You have non-small cell lung cancer (NSCLC).

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You are eligible for Parts B and C of the trial if you are receiving GS-9716 along with other cancer treatments.

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You have esophageal cancer.

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You have bone metastases and are currently taking bisphosphonates for pain relief.

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You can participate if you have brain metastases that are already being treated and are not getting worse.

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If you have cancer that has spread to your bones and you are currently taking bisphosphonates to help manage the pain, you may still be able to participate in the study as long as you have other areas of the body where the disease can be measured.

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You have prostate cancer that no longer responds to hormonal therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose date to pd or death, whichever occurs first (up to 39 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose date to pd or death, whichever occurs first (up to 39 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose date to pd or death, whichever occurs first (up to 39 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

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

Percentage of Patients Experiencing Dose-Limiting Toxicities (DLTs)

Secondary outcome measures

Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours (AUC0-24) for GS-9716

Maximum Observed Concentration (Cmax) for GS-9716

Parts B and C: Disease Control Rate (DCR)

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part C (Cohort C4): GS-9716 + sacituzumab govitecan-hziyExperimental Treatment2 Interventions

Patients will receive ≤ MTD GS-9716 in combination with sacituzumab govitecan-hziy.

Group II: Part C (Cohort C1): GS-9716 + docetaxelExperimental Treatment2 Interventions

Patients will receive ≤ MTD GS-9716 in combination with docetaxel.

Group III: Part B (Cohort B4): GS-9716 + sacituzumab govitecan-hziyExperimental Treatment2 Interventions

Patients will receive escalating doses of GS-9716 in combination with sacituzumab govitecan-hziy.

Group IV: Part B (Cohort B1): GS-9716 + docetaxelExperimental Treatment2 Interventions

Patients will receive escalating doses of GS-9716 in combination with docetaxel.

Group V: Part A: GS-9716 Dose-ExpansionExperimental Treatment1 Intervention

Patients will receive ≤ MTD of GS-9716.

Group VI: Part A: GS-9716 Dose-EscalationExperimental Treatment1 Intervention

Patients will receive escalating doses of GS-9716 to estimate MTD.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

FDA approved

0 / 8Eligibility criteria met

Find a site

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,050 Previous Clinical Trials

780,527 Total Patients Enrolled

Gilead Study DirectorStudy Director

Gilead Sciences

334 Previous Clinical Trials

185,450 Total Patients Enrolled

Media Library

GS-9716 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05006794 — Phase 1

Solid Tumors Research Study Groups: Part B (Cohort B1): GS-9716 + docetaxel, Part B (Cohort B4): GS-9716 + sacituzumab govitecan-hziy, Part C (Cohort C1): GS-9716 + docetaxel, Part C (Cohort C4): GS-9716 + sacituzumab govitecan-hziy, Part A: GS-9716 Dose-Escalation, Part A: GS-9716 Dose-Expansion

Solid Tumors Clinical Trial 2023: GS-9716 Highlights & Side Effects. Trial Name: NCT05006794 — Phase 1

GS-9716 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006794 — Phase 1

Frequently Asked Questions

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

Are there still opportunities for prospective participants in this trial?

"Confirmed. According to information on clinicaltrials.gov, this trial is currently enrolling participants with the original post date of September 15th 2021 and a recent update from November 10th 2022. There are 5 sites recruiting over 200 patients in total."

Answered by AI

Has GS-9716 been accorded official sanction by the FDA?

"The safety of GS-9716 is appraised as a 1 since this Phase 1 trial has only collected limited proof for its efficacy and security."

Answered by AI

What have been the other research endeavors associated with GS-9716?

"Presently, 752 clinical trials are actively underway for GS-9716 with 247 of these in their final phase. Most of the studies have been set up at a location within Woolloongabba, Queensland yet there exists an expansive network of 42846 sites conducting research on this therapeutic agent."

Answered by AI

For what conditions has GS-9716 demonstrated effectiveness?

"GS-9716 is a viable therapeutic option for neoplasm metastasis, as well as metastatic bladder cancer, advance directives, and urinary bladder."

Answered by AI

How many participants does this research involve?

"Gilead Sciences, the trial's sponsor, will be recruiting 205 appropriately qualified patients from START Mountain Region in Grand Rapids and START San Antonio in Texas."

Answered by AI

How many settings is this experiment supervised in?

"START Mountain Region in Grand Rapids, Michigan, START San Antonio in San Antonio, Texas and START Midwest in Portland Oregon are a few centres recruiting participants for this medical research. Additionally, there are 5 other clinical sites participating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies

2021. "Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05006794.