A Phase II Study of AS1411 in Renal Cell Carcinoma

September 24, 2009 updated by: Antisoma Research

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

The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Sacramento, California, United States, 95817
        • University of California, Davis Cancer Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St Francis Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center, University of Louisville
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the Overall Response Rate to AS1411

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antisoma Research

Investigators

  • Principal Investigator: Greg Smith, MD, Saint Francis Memorial Hospital
  • Principal Investigator: Harry Drabkin, MD, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Anticipated)

September 1, 2009

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

Study Record Updates

Last Update Posted (Estimate)

September 25, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1411-C-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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