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Sponsored by: |
NuRx Pharmaceuticals, Inc. |
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Information provided by: | NuRx Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00675870 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of NRX 195183 Therapy for Patients With Relapsed or Refractory Acute Promyelocytic Leukemia |
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 |
---|---|
1: Experimental |
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Exclusion Criteria:
Contact: Nonna Snider, BS/BA | 949-336-7111 | nsnider@nurxpharma.com |
Contact: Linda Gero | 949-336-7111 | lgero@nurxpharma.com |
United States, California | |
Sarcoma Oncology Center | Recruiting |
Santa Monica,, California, United States, 90403 | |
Contact: Victoria Chua 310-552-9999 vikychua@aol.com |
Responsible Party: | NuRx Pharmaceuticals, Inc. ( Roshantha A. Chandraratna, PhD, MBA, Chief Scientific Officer ) |
Study ID Numbers: | 195183-202 |
Study First Received: | May 7, 2008 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00675870 |
Health Authority: | United States: Food and Drug Administration |
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 |
Leukemia Acute promyelocytic leukemia Leukemia, Promyelocytic, Acute Tretinoin |
Arsenic trioxide Leukemia, Myeloid Leukemia, Myeloid, Acute |
Neoplasms Neoplasms by Histologic Type |