Back to resultsA Phase II Study of AS1411 in Renal Cell Carcinoma
Primary Purpose
Metastatic Renal Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AS1411
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Renal Cell Carcinoma focused on measuring renal cell carcinoma, rcc, kidney cancer
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)
Sites / Locations
- City of Hope
- University of California, Davis Cancer Center
- University of California San Francisco
- St Francis Hospital
- James Graham Brown Cancer Center, University of Louisville
- Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
AS1411 treatment
Outcomes
Primary Outcome Measures
To determine the Overall Response Rate to AS1411
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00740441
Brief Title
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
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
March 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Antisoma Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
renal cell carcinoma, rcc, kidney cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
AS1411 treatment
Intervention Type
Drug
Intervention Name(s)
AS1411
Intervention Description
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
Primary Outcome Measure Information:
Title
To determine the Overall Response Rate to AS1411
Secondary Outcome Measure Information:
Title
To measure progression free survival with AS1411
Title
To measure time to disease progression with AS1411
Title
To measure the duration of overall response and stable disease with AS1411
Title
To determine the safety and tolerability of two cycles of AS1411
Title
To assess the pharmacokinetic profile of AS1411
Title
To assess pharmacodynamic markers of AS1411
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Smith, MD
Organizational Affiliation
Saint Francis Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry Drabkin, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
St Francis Hospital
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
James Graham Brown Cancer Center, University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24242861
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.
Results Reference
derived
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A Phase II Study of AS1411 in Renal Cell Carcinoma
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