Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

May 9, 2008 updated by: NuRx Pharmaceuticals, Inc.

Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A common current therapeutic approach to APL uses oral ATRA and chemotherapy in induction and consolidation. This approach has significantly improved survival in newly diagnosed APL patients. However, approximately 30% of patients relapse. Recently, an approach involving the combination of oral ATRA and arsenic trioxide has been tested. The prognosis for relapsed patients is very poor. This study seeks to investigate NRX 195183 monotherapy in patients who have failed or are resistant to or are intolerant of any prior therapy.

Study Type

Interventional

Enrollment (Anticipated)

65

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
      • Santa Monica,, California, United States, 90403
        • Recruiting
        • Sarcoma Oncology Center
        • Contact:

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:

  • Clinical diagnosis of APL morphology or FAB M3 variant confirmed by RT-PCR assay or chromosome analysis/FISH showing t(15:17) translocation. Patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies:

    • ATRA
    • Cytotoxic chemotherapy
    • Arsenic trioxide
  • Patients must be 18 or older.
  • Bilirubin equal or less than 1.5 times the upper limit of normal.
  • Creatinine equal or less than 1.5 times the upper limit of normal.
  • Patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. Treatment under this protocol would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective means of birth control. There is an extremely high risk that a severely deformed infant will result if NRX 195183 is administered during pregnancy.

Exclusion Criteria:

  • Non-APL, AML patients should be excluded from the study.
  • Other serious illnesses which would limit survival to 6 months.
  • Psychiatric conditions which would prevent compliance with treatment or informed consent.
  • Uncontrolled or severe cardiovascular disease. This would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina.
  • AIDS or HIV positive patients, although HIV test is not required for accrual.

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: 1
Drug: NRX 195183 Soft Gelatin Capsule
Daily oral NRX 195183 administration for 90 days to assess CR rate. Patients with CR may continue maintenance therapy after a 2-week drug holiday. Maintenance therapy will consist of two 3-month daily oral NRX 195183 administration separated by a 2-week drug holiday.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Complete Remission
Time Frame: 90 Days
90 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Molecular Complete Remission
Time Frame: 9 months
9 months

Collaborators and Investigators

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

Sponsor

NuRx Pharmaceuticals, Inc.

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

April 1, 2008

Primary Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 12, 2008

Study Record Updates

Last Update Posted (Estimate)

May 12, 2008

Last Update Submitted That Met QC Criteria

May 9, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195183-202

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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