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A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Renal Cell Carcinoma

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Trial Information

A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma


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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the Overall Response Rate to AS1411

Safety Issue:

No

Principal Investigator

Greg Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Saint Francis Memorial Hospital

Authority:

United States: Food and Drug Administration

Study ID:

AS1411-C-202

NCT ID:

NCT00740441

Start Date:

August 2008

Completion Date:

March 2010

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • renal cell carcinoma
  • rcc
  • kidney cancer
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location
Medical University of South Carolina Charleston, South Carolina  29425-0721
City of Hope Duarte, California  91010
University of California San Francisco San Francisco, California  941104206
James Graham Brown Cancer Center, University of Louisville Louisville, Kentucky  40202
St Francis Hospital Indianapolis, Indiana  46107
University of California, Davis Cancer Center Sacramento, California  95817
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute Boston, Massachusetts  02115