Recruiting
Phase 2

NRX 195183

Sponsor:

NuRx Pharmaceuticals, Inc.

Code:

NCT00675870

Conditions

Acute Promyelocytic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NRX 195183 Soft Gelatin Capsule

Study Details

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

Conditions

Acute Promyelocytic Leukemia

Study ID

NCT00675870

Start date

Apr, 2008

Status verified date

May, 2008

Primary completion date

Apr, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Interventions

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 measure

  • Complete Remission [ Time Frame: 90 Days ]

Central Contacts and Locations

Central contacts

Nonna Snider, BS/BA

949-336-7111nsnider@nurxpharma.com

Linda Gero

949-336-7111lgero@nurxpharma.com

Locations

Sarcoma Oncology Center

Recruiting

Santa Monica,, California, United States, 90403

Contacts

Victoria Chua

310-552-9999vikychua@aol.com

More Information

Sponsor

NuRx Pharmaceuticals, Inc.

Last update posted

May 12, 2008

Last verified

May, 2008

Keywords

  • Acute Promyelocytic Leukemia
  • Cancer
  • Leukemia
  • APL
  • ATRA
  • Tretinoid
  • Vesanoid
  • Retinoic Acid Receptor Alpha
  • All Trans Retinoic Acid
  • Arsenic Trioxide
  • Trisenox
  • Retinoid
  • Relapsed or Refractory Acute Promyelocytic Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NuRx Pharmaceuticals, Inc. on 2008-05-12.