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

Sponsor

NuRx Pharmaceuticals, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00675870

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

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 :

Apr 1, 2008

Anticipated Primary Completion Date :

Apr 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Complete Remission [90 Days]

Secondary Outcome Measures

Molecular Complete Remission [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.