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A Phase II Study of AS1411 in Renal Cell Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Antisoma Research.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT00740441
First received: August 22, 2008
Last updated: September 24, 2009
Last verified: September 2009
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Antisoma Research:

Primary Outcome Measures:
  • To determine the Overall Response Rate to AS1411 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure progression free survival with AS1411 [ Designated as safety issue: No ]
  • To measure time to disease progression with AS1411 [ Designated as safety issue: No ]
  • To measure the duration of overall response and stable disease with AS1411 [ Designated as safety issue: No ]
  • To determine the safety and tolerability of two cycles of AS1411 [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetic profile of AS1411 [ Designated as safety issue: No ]
  • To assess pharmacodynamic markers of AS1411 [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chris Smyth, Antisoma
ClinicalTrials.gov Identifier: NCT00740441     History of Changes
Other Study ID Numbers: AS1411-C-202
Study First Received: August 22, 2008
Last Updated: September 24, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013