ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00675870
Recruitment Status : Unknown
Verified May 2008 by NuRx Pharmaceuticals, Inc..
Recruitment status was:  Recruiting
First Posted : May 12, 2008
Last Update Posted : May 12, 2008
Sponsor:
Information provided by:
NuRx Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Acute Promyelocytic Leukemia Drug: NRX 195183 Soft Gelatin Capsule Phase 2

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  (Clinical Trial)
Estimated Enrollment : 65 participants
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
Study Start Date : April 2008
Estimated Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

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.




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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.

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): NCT00675870


Contacts
Contact: Nonna Snider, BS/BA 949-336-7111 nsnider@nurxpharma.com
Contact: Linda Gero 949-336-7111 lgero@nurxpharma.com

Locations
United States, California
Sarcoma Oncology Center Recruiting
Santa Monica,, California, United States, 90403
Contact: Victoria Chua    310-552-9999    vikychua@aol.com   
Sponsors and Collaborators
NuRx Pharmaceuticals, Inc.

Responsible Party: Roshantha A. Chandraratna, PhD, MBA, Chief Scientific Officer, NuRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00675870     History of Changes
Other Study ID Numbers: 195183-202
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: May 2008

Keywords provided by NuRx Pharmaceuticals, Inc.:
Acute Promyelocytic Leukemia
Relapsed or Refractory Acute Promyelocytic Leukemia
Cancer
Leukemia
APL
ATRA
Tretinoid
Vesanoid
Retinoic Acid Receptor Alpha
All Trans Retinoic Acid
Arsenic Trioxide
Trisenox
Retinoid

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid