A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors
This study will be conducted using a traditional 3 + 3 dose escalation study design.
Enrollment of at least 3 subjects is planned for each dosing cohort. The decision to expand
a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs)
in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to
ASP3026. The Safety Data Review Committee may elect to enroll additional subjects in a
cohort to further evaluate the dose level. Each cycle will include 28 days of continuous
dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation
criteria is met.
The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing
schedule at which < 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose,
as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose
(RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety
and tolerability.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Up to 30 days after last subject discontinues treatment
No
Use Central Contact
Study Chair
Astellas Pharma Inc
Japan: Pharmaceuticals and Medical Devices Agency
3026-CL-0102
NCT01401504
May 2011
March 2014
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