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A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors
Houston, TX
Phase 1
Waitlist Available
Research Sponsored by Sihuan Pharmaceutical Holdings Group Ltd.
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 5 years
Awards & highlights
No Placebo-Only Group
Summary
The purpose of this study is to determine the maximum tolerated dose of KBP-5209 as a single agent when given orally to adult patients with advanced solid tumors that have progressed despite standard therapy, or where there is no standard therapy.
See full description
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: KBP-5209Experimental Treatment1 Intervention
Dose escalation for KBP-5209 will initially follow a modified accelerated titration design with a starting dose of 20 mg QD. Early dose escalation will proceed with one-patient cohorts and 100% dose increments (ie, dose doubling) until a patient experiences a DLT, at which point the cohorts will move to a 3+3 design. Treatment will continue until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons. A cycle is defined as continuous treatment for 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KBP-5209
2015
Completed Phase 1
~40
Find a Location
Closest Location:Indiana University Melvin and Bren Simon Cancer Center· Indianapolis, IN· 168 miles
Who is running the clinical trial?
CovanceIndustry Sponsor
123 Previous Clinical Trials
13,217 Total Patients Enrolled
Sihuan Pharmaceutical Holdings Group Ltd.Lead Sponsor
22 Previous Clinical Trials
2,714 Total Patients Enrolled
XuanZhu Pharma Co., Ltd.UNKNOWN