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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 dose-limiting toxicity will be evaluated during the 4 - week dose escalation phase.
Awards & highlights
Study Summary
This trial is testing a new drug, GNS561, to see if it is safe and works well in patients with primary or secondary liver cancer.
Eligible Conditions
- Liver Cancer
- Intrahepatic Cholangiocarcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ dose-limiting toxicity will be evaluated during the 4 - week dose escalation phase.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~dose-limiting toxicity will be evaluated during the 4 - week dose escalation phase.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-Limiting Toxicity
Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
Dose escalation using 3+3 design with dose limiting toxicity (DLT) observation period of 28 days.
Group II: Dose ExpansionExperimental Treatment1 Intervention
Additional patients will be enrolled into the recommended dose. These additional patients will undergo all of the same assessments as the patients enrolled in dose escalation with the exception of PK sampling.
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Who is running the clinical trial?
Genoscience PharmaLead Sponsor
3 Previous Clinical Trials
208 Total Patients Enrolled
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