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Tracking Information | |
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First Received Date † | September 7, 2007 |
Last Updated Date | December 19, 2008 |
Start Date † | November 2005 |
Current Primary Outcome Measures † |
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of RTA 744 Injection in the patient population studied and to determine the qualitative and quantitative toxic effects of RTA 744 Injection. [ Time Frame: at end of first cycle for each patient cohort ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures † | Same as current |
Change History | Complete list of historical versions of study NCT00526812 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures † |
To characterize the multiple-dose pharmacokinetics of RTA 744 and to document any potential antitumor activity of RTA 744 in those patients with measurable disease. [ Time Frame: end of study ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures † | Same as current |
Descriptive Information | |
Brief Title † | A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas |
Official Title † | A Phase I Dose-Finding and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent or Refractory Anaplastic Astrocytoma (AA), Anaplastic Oligodendroglioma (AO), Anaplastic Mixed Oligo-Astrocytoma (AOA), Glioblastoma Multiforme (GBM) or Gliosarcoma (GS), With or Without Concurrent Treatment With Enzyme-Inducing Anticonvulsant Therapy |
Brief Summary | This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas. |
Detailed Description | Malignant gliomas, glioblastoma multiforme and anaplastic astrocytoma, are rapidly growing primary brain tumors associated with a high degree of morbidity and mortality. Despite aggressive treatment, the median survival rate for GBM is approximately 12 months, with two-year survival rates no more than 8 to 12%, while median survival for patients with AA ranges from 2 to 3 years from time of first diagnosis. RTA 744 is a close chemical analogue of the well characterized anti-cancer agent doxorubicin. Unlike doxorubicin, RTA 744 has shown ability to cross the blood brain barrier and to achieve high concentration in CNS tumor tissue in animal models. It will be administered by i.v. infusions either daily for 3 consecutive days repeated every three weeks, or once weekly for 4 consecutive weeks repeated every 5 weeks. Once the maximum tolerated dose is determined
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Study Phase | Phase I |
Study Type † | Interventional |
Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Condition † | Glioma |
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |
Recruitment Status † | Completed |
Estimated Enrollment † | 50 |
Completion Date | |
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) |
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts †† | |
Location Countries † | United States |
Expanded Access Status | |
Administrative Information | |
NCT ID † | NCT00526812 |
Responsible Party | Reata Pharmaceuticals, Inc |
Secondary IDs †† | |
Study Sponsor † | Reata Pharmaceuticals, Inc. |
Collaborators †† | |
Investigators † | |
Information Provided By | Reata Pharmaceuticals, Inc. |
Verification Date | December 2008 |
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |