Study of AS1411 in Advanced Solid Tumours
- Registration Number
- NCT00881244
- Lead Sponsor
- Antisoma Research
- 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 clinical and biological responses to AS1411 therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 AS1411 AS1411
- Primary Outcome Measures
Name Time Method To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of AS1411
- Secondary Outcome Measures
Name Time Method To determine the pharmacokinetic (PK) distribution and profile of AS1411 To obtain preliminary evidence of clinical and biological responses to AS1411
Trial Locations
- Locations (1)
James Graham Brown Cancer Center, University of Louisville
🇺🇸Louisville, Kentucky, United States