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Sponsors and Collaborators: |
The Methodist Hospital System Bayer ONYX Pharmaceuticals |
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Information provided by: | The Methodist Hospital System |
ClinicalTrials.gov Identifier: | NCT00445042 |
The purpose of this study is to determine the safety and toxicity levels of Dose Escalated Sorafenib in the treatment of patients with renal cancer.
Condition | Intervention | Phase |
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Carcinoma, Renal Cell |
Drug: Sorafenib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Sorafenib in Patients With Metastatic Renal Cell Carcinoma |
Enrollment: | 71 |
Study Start Date: | November 2005 |
Study Completion Date: | October 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Intrapatient dose escalation study of sorafenib
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Drug: Sorafenib
The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the protocol, providing no dose limiting toxicity (Grade 3 or 4) is observed.
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Because tumors may have multiple mechanisms to induce angiogenesis, blockade with sorafenib may demonstrate efficacy. Doses of sorafenib (400 mg b.i.d.) as a single agent is with minimal toxicity, presents an opportunity to explore a more intensive drug administration. This study will allow individual patient titration (e,g,, intrapatient dose escalation) as per protocol.
This provides the basis for the dose escalation development of sorafenib. The study is designed to evaluate the ability for patients to dose escalate.
Secondary endpoints include; response, time to progression, and overall survival in patients with MRCC. Tissue correlation to evaluate the impact of expression of receptor on clinical outcome will be retrospectively performed. Laboratory correlation of plasma VEGF levels will be correlated and evaluated to clinical outcome.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
The Methodist Hospital Research Institute | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Robert J Amato, DO | The Methodist Hospital Research Institute |
Responsible Party: | The Methodist Hospital Research Institute ( Robert J. Amato, DO ) |
Study ID Numbers: | Sorafenib-RCC-01, 03-0194-05 |
Study First Received: | March 7, 2007 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00445042 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Metastatic Renal Cell Carcinoma Metastatic RCC Kidney Cancer M3thodist |
Urinary Tract Neoplasm Kidney Cancer Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Carcinoma Renal Cancer |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Urogenital Neoplasms Urologic Neoplasms Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Neoplasms |
Neoplasms by Site Urologic Diseases Kidney Neoplasms Therapeutic Uses Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial |