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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00124527 |
Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.
Condition | Intervention | Phase |
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Thyroid Cancer |
Drug: Irofulven + capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Clinical Trial of Bi-Weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | March 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Please note: There are additional criteria that must be met in order to be eligible for this study.
United States, Colorado | |
Aurora, Colorado, United States | |
United States, Ohio | |
Columbus, Ohio, United States | |
Argentina | |
Salta, Argentina | |
France | |
Lyon, France | |
Toulouse, France | |
Villejuif, France | |
Peru | |
Lima, Peru | |
Russian Federation | |
Moscow, Russian Federation | |
Obninsk, Russian Federation | |
Ukraine | |
Kiev, Ukraine |
Study ID Numbers: | IROF-019 |
Study First Received: | July 26, 2005 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00124527 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Irofulven, Thyroid Cancer |
Antimetabolites Capecitabine Radiation-Sensitizing Agents Thyroid Neoplasms Head and Neck Neoplasms Irofulven |
Endocrine System Diseases Antineoplastic Agents, Alkylating Endocrinopathy Alkylating Agents Thyroid Diseases Endocrine Gland Neoplasms |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Thyroid Neoplasms Antineoplastic Agents Physiological Effects of Drugs Endocrine System Diseases Pharmacologic Actions Neoplasms |
Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Head and Neck Neoplasms Irofulven Antineoplastic Agents, Alkylating Alkylating Agents Thyroid Diseases Endocrine Gland Neoplasms |