A Phase II Study of AS1411 in Renal Cell Carcinoma
- Registration Number
- NCT00740441
- Lead Sponsor
- Antisoma Research
- Brief Summary
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology
- Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor)
Exclusion Criteria
- Collecting duct histology
- A history of bleeding disorders or currently taking oral vitamin K antagonise medication
- Unstable brain metastases
- History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A AS1411 AS1411 treatment
- Primary Outcome Measures
Name Time Method To determine the Overall Response Rate to AS1411
- Secondary Outcome Measures
Name Time Method To measure progression free survival with AS1411 To measure time to disease progression with AS1411 To measure the duration of overall response and stable disease with AS1411 To determine the safety and tolerability of two cycles of AS1411 To assess the pharmacokinetic profile of AS1411 To assess pharmacodynamic markers of AS1411
Trial Locations
- Locations (7)
City of Hope
🇺🇸Duarte, California, United States
University of California, Davis Cancer Center
🇺🇸Sacramento, California, United States
James Graham Brown Cancer Center, University of Louisville
🇺🇸Louisville, Kentucky, United States
St Francis Hospital
🇺🇸Beech Grove, Indiana, United States
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of California San Francisco
🇺🇸San Francisco, California, United States