Safety Study of Increasing Doses of CKD-516 in Patients With Advanced Solid Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 30
Summary
- Conditions
- Unspecified Adult Solid Tumor - Protocol Specific
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 75 years
- Gender
- Both males and females
Description
This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 4, 8, 11 every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose (MTD) is determined....
This is an open label, dose escalation study. Patients receive CKD-516 IV over 30 minutes on day 1, 4, 8, 11 every 3 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3~6 patients receive escalating doses of CKD-516 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Tracking Information
- NCT #
- NCT01560325
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yung-Jue Bang Seoul National University Hospital
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