A Phase II Study of AS1411 in Renal Cell Carcinoma
A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma
1 other identifier
interventional
30
1 country
7
Brief Summary
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2008
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 22, 2008
CompletedFirst Posted
Study publicly available on registry
August 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedSeptember 25, 2009
September 1, 2009
1.1 years
August 22, 2008
September 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the Overall Response Rate to AS1411
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (1)
A
EXPERIMENTALAS1411 treatment
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
City of Hope
Duarte, California, 91010, United States
University of California, Davis Cancer Center
Sacramento, California, 95817, United States
University of California San Francisco
San Francisco, California, 94143, United States
St Francis Hospital
Beech Grove, Indiana, 46107, United States
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, 40202, United States
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Related Publications (1)
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.
PMID: 24242861DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Greg Smith, MD
Saint Francis Hospital
- PRINCIPAL INVESTIGATOR
Harry Drabkin, MD
Medical University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 22, 2008
First Posted
August 25, 2008
Study Start
August 1, 2008
Primary Completion
September 1, 2009
Study Completion
March 1, 2010
Last Updated
September 25, 2009
Record last verified: 2009-09