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FX-909 for Bladder Cancer
Phase 1
Recruiting
Led By Gopa Iyer, MD
Research Sponsored by Flare Therapeutics 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 through study completion, an average of 3 years
Awards & highlights
Study Summary
This trial will study the safety and tolerability of a drug called FX-909 in people with advanced solid tumors, like urothelial carcinoma. Results will show the best dose for patients and any side effects.
Who is the study for?
This trial is for adults (18+) with advanced solid tumors, including urothelial carcinoma, that have worsened after standard treatments or when such treatments aren't suitable. Participants must be in relatively good health otherwise (ECOG status 0-2), able to consent, and have a tumor sample available. Pregnant or breastfeeding women, individuals with recent serious heart issues, uncontrolled infections like HIV/HCV, severe lung function impairment, certain gastrointestinal disorders, or those who've had recent chemotherapy are excluded.Check my eligibility
What is being tested?
The study tests the safety and appropriate dosage of FX-909 taken orally by patients with advanced cancers. It involves daily intake of FX-909 tablets while monitoring effects through regular site visits for blood tests and imaging scans like CT/MRI to assess how the body responds to the treatment over time.See study design
What are the potential side effects?
While specific side effects of FX-909 are not listed here as it's under investigation, participants will record any outcomes from taking the drug which may include typical cancer medication side effects such as nausea, fatigue, digestive issues or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess dose-limiting toxicities, the incidence and severity of adverse events and serious adverse events associated with FX-909 (Safety and Tolerability)
Secondary outcome measures
To characterize the pharmacokinetic profile of FX 909 in patients with advanced solid malignancies
To characterize the pharmacokinetic profile of FX-909 in patients with advanced solid malignancies
To define the preliminary recommended phase 2 dose of FX-909, and/or maximum tolerated dose (MTD)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Expansion ExpansionExperimental Treatment1 Intervention
When a preliminary RP2D has been identified (this dose may be equal to or below the MTD) evaluate the antitumor activity in locally advanced (unresectable) and metastatic urothelial carcinoma.
Group II: Dose EscalationExperimental Treatment1 Intervention
3+3 design, 5 dose levels,
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Who is running the clinical trial?
Flare Therapeutics Inc.Lead Sponsor
Gopa Iyer, MDPrincipal InvestigatorMemorial Slone Kettering
1 Previous Clinical Trials
271 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced, cannot be surgically removed, and has not responded to or cannot be treated with standard therapies.I have stable brain metastases with no symptoms after radiotherapy.My side effects from previous treatments are mild or have returned to normal, except for hair loss, hearing loss, skin color changes, hormone issues treated with medication, and mild nerve pain.I haven't had major surgery in the last 4 weeks.I have lipodystrophy or need medication that causes it.I am HIV positive but my viral load is undetectable with treatment.I have active hepatitis C or have been cured with no detectable virus.I need high doses of steroids.I do not require any treatment that is not allowed in this study.I can understand and am willing to sign a consent form.I have a history of heart disease.I am 18 years old or older.I am able to care for myself and perform daily activities.I can provide a recent tumor sample or agree to a new biopsy.I have chronic hepatitis B but my PCR test for the virus is negative.I have been diagnosed with pancreatitis before or had acute pancreatitis in the last 6 months.My heart's electrical activity is normal and I don't have a family history of sudden heart-related deaths.My bladder cancer is advanced, has specific genetic changes, and hasn't responded to standard treatments.I do not have any untreated serious infections.I haven't had cancer treatment within the last 2 weeks or 5 half-lives, or 4 weeks if it was biological therapy.I recently had radiation therapy without enough time before starting the study drug.I had cancer before, but it was cured with surgery alone over 2 years ago.I am currently pregnant or breastfeeding.I have not had treatments targeting PPARG or RXRA.I need extra oxygen or my oxygen levels are usually below 92%.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Expansion Expansion
- Group 2: Dose Escalation
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any attendant risks associated with Dose Escalation?
"The safety profile of Dose Escalation is estimated to be a 1 due to the fact that this clinical trial is in its phase one stage, where limited information exists on both efficacy and security."
Answered by AI
Is registration for this research endeavor still open?
"Clinicaltrials.gov's records indicate that this medical trial is no longer recruiting patients, as the last update to its listing occured on June 26th 2023. Despite this fact, there are still 2538 other studies actively enrolling participants at present."
Answered by AI
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