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

Acute Promyelocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00675870
• Other study ID #: 195183-202
• Status: Recruiting
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: May 9, 2008
• Start date: April 2008

Study information

• Verified date: May 2008
• Source: NuRx Pharmaceuticals, Inc.
• Contact: Nonna Snider, BS/BA
• Phone: 949-336-7111
• Email: nsnider[@]nurxpharma.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

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.

Locations

Country	Name	City	State
United States	Sarcoma Oncology Center	Santa Monica,	California

Sponsors (1)

Lead Sponsor	Collaborator
NuRx Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Remission		90 Days	No
Secondary	Molecular Complete Remission		9 months	No