Clinical Trials Directory

Trials / Completed

CompletedNCT01049893

Dose Finding, Safety and Tolerability Study for AC220 to Treat Advanced Solid Tumors

A Phase 1 Open-Label, Dose Finding, Safety and Tolerability Study of AC220 Administered Daily to Patients With Advanced Solid Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Daiichi Sankyo · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without food and without any rest periods, as long as there is no evidence of disease progression or unacceptably severe adverse events (AEs) related to the study drug.

Detailed description

A phase 1 open-label, dose finding study of AC220 in patients with solid tumors.

Conditions

Interventions

TypeNameDescription
DRUGCompound AC220Precomplexed powder in bottle formulation supplied as 135 mg in a 60 cc polyethylene terephthalate (PET) plastic bottle. Requires reconstitution by a pharmacist, must be stored securely, and protected from light.

Timeline

Start date
2010-01-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2010-01-15
Last updated
2019-02-12

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01049893. Inclusion in this directory is not an endorsement.

Dose Finding, Safety and Tolerability Study for AC220 to Treat Advanced Solid Tumors (NCT01049893) · Clinical Trials Directory