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Tyrosine Kinase Inhibitor
X4P-001 for Renal Cell Carcinoma
Phase 1 & 2
Waitlist Available
Research Sponsored by X4 Pharmaceuticals
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 up to 80 weeks, from time of enrollment through study completion or early termination
Awards & highlights
Study Summary
This trial will test the safety and effectiveness of a new drug, X4P-001, for treating advanced renal cell carcinoma.
Eligible Conditions
- Renal Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 80 weeks, from time of enrollment through study completion or early termination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 80 weeks, from time of enrollment through study completion or early termination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Secondary outcome measures
Area Under the Curve (AUC)
Disease Control Rate
Maximum Plasma Concentration (Cmax)
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part CExperimental Treatment1 Intervention
X4P-001 monotherapy
Group II: Part BExperimental Treatment2 Interventions
Randomized assignment to one of two regimens:
X4P-001 at the Part A maximum tolerated dose (MTD), in combination with axitinib
X4P-001 at 0.5x Part A MTD, in combination with axitinib
Group III: Part AExperimental Treatment2 Interventions
X4P-001 + axitinib dose escalation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
X4P-001
2016
Completed Phase 2
~100
Axitinib
FDA approved
Find a Location
Who is running the clinical trial?
X4 PharmaceuticalsLead Sponsor
9 Previous Clinical Trials
288 Total Patients Enrolled
Frequently Asked Questions
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