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CWP232291 for Acute Myeloid Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by JW Pharmaceutical
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 3rd cycle (each cycle = 28 days), cycle 1 day 1: pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in part a and at cycle 1 day 1: pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in part b.
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective in people with relapsed or refractory AML. The primary objective is to assess the efficacy of the drug in combination with another drug, cytarabine.
Eligible Conditions
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3rd cycle (each cycle = 28 days), cycle 1 day 1: pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in part a and at cycle 1 day 1: pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in part b.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3rd cycle (each cycle = 28 days), cycle 1 day 1: pre, 0.5hr, 1hr, 2hr, 3hr, 4hr, 5hr, 8hr, and 24hr after the start of infusion in part a and at cycle 1 day 1: pre, 2hr, 4hr, 8hr, and 24hr after the start of infusion in part b.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended Phase 2 dose
Secondary outcome measures
AUC0-t as a Pharmacokinetic (PK) assessments for CWP232291
AUC0-τ as a Pharmacokinetic (PK) assessments for CWP232291
AUC0-∞ as a Pharmacokinetic (PK) assessments for CWP232291
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: CWP232291 in combination with cytarabine (ara-C)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CWP232291
2011
Completed Phase 1
~70
Find a Location
Who is running the clinical trial?
JW PharmaceuticalLead Sponsor
67 Previous Clinical Trials
42,547 Total Patients Enrolled
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