Clinical trial NCT00740441: A Phase II Study of AS1411 in Renal Cell Carcinoma
Official title: A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma
Keywords: renal cell carcinoma
rcc
kidney cancer
Lead sponsor: Antisoma Research
Sponsor class: INDUSTRY
First posted: 2008-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma


Eligibility criteria: 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)

Primary outcomes:
measure: To determine the Overall Response Rate to AS1411
Secondary outcomes:
measure: To measure progression free survival with AS1411
measure: To measure time to disease progression with AS1411
measure: To measure the duration of overall response and stable disease with AS1411
measure: To determine the safety and tolerability of two cycles of AS1411
measure: To assess the pharmacokinetic profile of AS1411
measure: To assess pharmacodynamic markers of AS1411
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Sacramento
country: United States
facility: University of California, Davis Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Beech Grove
country: United States
facility: St Francis Hospital
state: Indiana
city: Louisville
country: United States
facility: James Graham Brown Cancer Center, University of Louisville
state: Kentucky
city: Boston
country: United States
facility: Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
state: Massachusetts
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Saint Francis Hospital
name: Greg Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Harry Drabkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenberg JE, Bambury RM, Van Allen EM, Drabkin HA, Lara PN Jr, Harzstark AL, Wagle N, Figlin RA, Smith GW, Garraway LA, Choueiri T, Erlandsson F, Laber DA. A phase II trial of AS1411 (a novel nucleolin-targeted DNA aptamer) in metastatic renal cell carcinoma. Invest New Drugs. 2014 Feb;32(1):178-87. doi: 10.1007/s10637-013-0045-6. Epub 2013 Nov 16.