Metastatic Renal Cell Carcinoma
Conditions
Keywords
renal cell carcinoma, rcc, kidney cancer
Brief summary
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma
Interventions
DRUGAS1411
AS1411 40 mg/kg/day) will be administered on days 1-4 via a continuous iv infusion every 28-day cycle for up to 2 cycles
Sponsors
Antisoma Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the Overall Response Rate to AS1411 | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure time to disease progression with AS1411 | — |
| To measure the duration of overall response and stable disease with AS1411 | — |
| To measure progression free survival with AS1411 | — |
| To assess the pharmacokinetic profile of AS1411 | — |
| To assess pharmacodynamic markers of AS1411 | — |
| To determine the safety and tolerability of two cycles of AS1411 | — |
Countries
United States
Outcome results
None listed