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

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 May 2008 by NuRx Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
Information provided by:
NuRx Pharmaceuticals, Inc. Identifier:
First received: May 7, 2008
Last updated: May 9, 2008
Last verified: May 2008
The purpose of this study is to determine whether NRX 195183 is effective in the treatment of relapsed or refractory Acute Promyelocytic Leukemia

Condition Intervention Phase
Acute Promyelocytic Leukemia Drug: NRX 195183 Soft Gelatin Capsule Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

Resource links provided by NLM:

Further study details as provided by NuRx Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Complete Remission [ Time Frame: 90 Days ]

Secondary Outcome Measures:
  • Molecular Complete Remission [ Time Frame: 9 months ]

Estimated Enrollment: 65
Study Start Date: April 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00675870

Contact: Nonna Snider, BS/BA 949-336-7111
Contact: Linda Gero 949-336-7111

United States, California
Sarcoma Oncology Center Recruiting
Santa Monica,, California, United States, 90403
Contact: Victoria Chua    310-552-9999   
Sponsors and Collaborators
NuRx Pharmaceuticals, Inc.
  More Information

Responsible Party: Roshantha A. Chandraratna, PhD, MBA, Chief Scientific Officer, NuRx Pharmaceuticals, Inc. Identifier: NCT00675870     History of Changes
Other Study ID Numbers: 195183-202
Study First Received: May 7, 2008
Last Updated: May 9, 2008

Keywords provided by NuRx Pharmaceuticals, Inc.:
Acute Promyelocytic Leukemia
Relapsed or Refractory Acute Promyelocytic Leukemia
Retinoic Acid Receptor Alpha
All Trans Retinoic Acid
Arsenic Trioxide

Additional relevant MeSH terms:
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid, Acute
Leukemia, Myeloid processed this record on September 19, 2017