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A Phase II Study of AS1411 in Renal Cell Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Antisoma Research.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00740441
First Posted: August 25, 2008
Last Update Posted: September 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Antisoma Research
  Purpose
The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma

Condition Intervention Phase
Metastatic Renal Cell Carcinoma Drug: AS1411 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Antisoma Research:

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

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
AS1411 treatment
Drug: AS1411
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00740441


Locations
United States, California
City of Hope
Duarte, California, United States, 91010
University of California, Davis Cancer Center
Sacramento, California, United States, 95817
University of California San Francisco
San Francisco, California, United States, 94143
United States, Indiana
St Francis Hospital
Beech Grove, Indiana, United States, 46107
United States, Kentucky
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Antisoma Research
Investigators
Principal Investigator: Greg Smith, MD Saint Francis Memorial Hospital
Principal Investigator: Harry Drabkin, MD Medical University of South Carolina
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chris Smyth, Antisoma
ClinicalTrials.gov Identifier: NCT00740441     History of Changes
Other Study ID Numbers: AS1411-C-202
First Submitted: August 22, 2008
First Posted: August 25, 2008
Last Update Posted: September 25, 2009
Last Verified: September 2009

Keywords provided by Antisoma Research:
renal cell carcinoma
rcc
kidney cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases