NCT01401504

Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors

A Phase I, Non-randomized, Open-label, Repeat Oral Administration Study of ASP3026 in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).

Detailed description

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ASP3026	oral

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-07-25
• Last updated: 2014-06-11

Locations

1 site across 1 country: Japan