Brief Title
Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
Official Title
Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Complete Remission
Secondary Outcome
Molecular Complete Remission
Condition
Acute Promyelocytic Leukemia
Intervention
NRX 195183 Soft Gelatin Capsule
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
April 2008
Primary Completion Date
April 2010
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 949-336-7111, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00675870
Organization ID
195183-202
Study Sponsor
NuRx Pharmaceuticals, Inc.
Study Sponsor
, ,
Verification Date
May 2008