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Trial record 3 of 115 for:    "Acute promyelocytic leukemia"
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Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by NuRx Pharmaceuticals, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
NuRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00675870
First received: May 7, 2008
Last updated: May 9, 2008
Last verified: May 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Acute Promyelocytic Leukemia
 Drug: NRX 195183 Soft Gelatin Capsule
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Leukemia
U.S. FDA Resources

Further study details as provided by NuRx Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Complete Remission [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Molecular Complete Remission [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 65
Study Start Date: April 2008
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

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
Study First Received: May 7, 2008
Last Updated: May 9, 2008
Health Authority: United States: Food and Drug Administration

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
 Tretinoin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2013