Status:
COMPLETED
Study of AS1411 in Advanced Solid Tumours
Lead Sponsor:
Antisoma Research
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 cl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00881244
Start Date
September 1 2003
End Date
February 1 2007
Last Update
April 15 2009
Active Locations (1)
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1
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, United States, 40202