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Sponsored by: |
Reata Pharmaceuticals, Inc. |
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Information provided by: | Reata Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00526812 |
This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.
Condition | Intervention | Phase |
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Glioma |
Drug: RTA 744 Drug: RTA 744 injection |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 50 |
Study Start Date: | November 2005 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Receive study drug for three consecutive days, Cycle repeated every 21 days.
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Drug: RTA 744
Aqueous solution added to 10%D/W and infused over 2 hours on three consecutive days. 5 mg vials contain 1 mg/ml.
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Group C: Experimental
Receive study drug once a week for four consecutive weeks. Repeat cycle every 5 weeks.
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Drug: RTA 744 injection
Aqueous solution in 1mg/ml. Doses are escalated. Drug is infused intravenously over 2 hours one day a week for four consecutive weeks.
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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 , a new group of patients will be enrolled into the study to evaluate the tolerability and MTD when administered on an expanded schedule (once a week).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA School of Medicine, Department of Neurology | |
Los Angeles, California, United States, 90095 | |
United States, Texas | |
The University of Texas M. D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75309 | |
Baylor University Medical Center: Neuro-Oncology Associates | |
Dallas, Texas, United States, 75246 |
Responsible Party: | Reata Pharmaceuticals, Inc |
Study ID Numbers: | RTA 744-C-0401 |
Study First Received: | September 7, 2007 |
Last Updated: | December 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00526812 |
Health Authority: | United States: Food and Drug Administration |
Neuroectodermal Tumors Signs and Symptoms Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |