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Sponsored by: |
Norris Comprehensive Cancer Center |
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Information provided by: | Norris Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00630760 |
This phase I study will determine the safety profile of NRX 194204 on this schedule; it will evaluate the pharmacokinetic profile of NRX 194204 in cancer patients; and will investigate anti-tumor activity as manifested by standard response criteria, or by tumor markers.
Condition | Intervention | Phase |
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Refractory Malignancies |
Drug: NRX 194204 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multiple-Center, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of Oral NRX 194204 Capsule Administered Daily for a Minimum of 4 Weeks in Patients With Refractory Malignancies |
Estimated Enrollment: | 20 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
NRX 194204 capsules in escalating doses, starting at 3mg/m2.
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Drug: NRX 194204
NRX 194204 capsules given 3mg/m2 daily x 28 days. Repeated until PD
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Claire Hughlett, RN | 323/865-0593 | Hughlett_C@ccnt.usc.edu |
United States, California | |
USC/Norris Comprehensive Cancer Center | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Zeno Ashai 323-865-0454 Ashai_Z@ccnt.hsc.edu | |
Principal Investigator: David Quinn, MD |
Responsible Party: | University of Southern California ( David Quinn, MD ) |
Study ID Numbers: | 0C-07-6 |
Study First Received: | February 28, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00630760 |
Health Authority: | United States: Institutional Review Board |
Neoplasms |