Study of AS1411 in Advanced Solid Tumours

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

A Phase I open label study of AS1411 in advanced solid tumours. Objectives include determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain preliminary evidence of clinical and biological responses to AS1411 therapy.

Key facts

Study ID

NCT00881244

Run by

Antisoma Research

People needed

30

Starts

2003-09-01

Expected to finish

2007-02-01

Last updated by the study team

2009-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with advanced solid tumours that were refractory to conventional/standard treatment
• Age >/ 18 years
• ECOG performance status </ 2 (Karnofsky >/60%
• Life expectancy >/ 8 weeks
• Adequate organ and marrow function

You may not qualify if…

• Radiotherapy or chemotherapy in the 4 weeks before study entry (6 weeks for nitrosourea or mitomycin C
• Lack of recovery from adverse events (AEs) caused by agents administered before study entry; current use of other investigational agent(s)
• Uncontrolled brain metastases including a need for corticosteroid therapy
• Pregnancy
• Uncontrolled intercurrent illness
• Psychiatric illness/social situations that could limit compliance

Where it is running

• James Graham Brown Cancer Center, University of Louisville — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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