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Sponsors and Collaborators: |
University Hospital, Bordeaux Pfizer |
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Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00510640 |
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during previous studies with sunitinib (an angiogenic oncology drug also known as Sutent), this study, THYSU, is justified to evaluate the efficacy of sunitinib in metastatic thyroid carcinoma. Furthermore, the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine. When radioiodine becomes ineffective, there is no standard treatment despite some use of chemotherapy.
The objective of the trial is to determine the objective tumor response rate (efficacy) in patients with locally advanced or metastatic anaplastic, differentiated or medullary thyroid carcinoma treated with sunitinib; a secondary objective is to evaluate the safety of sunitinib in these patients.
The THYSU trial is a phase II, French multi-center study. This trial's plan is to enroll 75 patients with locally advanced or metastatic anaplastic, differentiated or medullar thyroid carcinoma.
Condition | Intervention | Phase |
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Cancer Thyroid Carcinoma |
Drug: Sunitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 of Sunitinib (Sutent) in Patients With Locally Advanced or Metastatic Anaplastic, Differentiated or Medullar Thyroid Cancer |
Estimated Enrollment: | 75 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2011 |
Arms | Assigned Interventions |
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Sunitinib: Experimental
Sunitinib will be administered orally daily for 4 weeks followed by a 2-week rest; the daily starting dose will be 50 mg with a provision for dose reduction based on tolerability. All patients will receive repeated cycles until disease progression or occurrence of severe toxicity.
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Drug: Sunitinib
Capsule, 12.5 or 50 mg, starting dose level 50 mg daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alain Ravaud, Pr. | 33 (0) 5 56 79 58 08 | alain.ravaud@chu-bordeaux.fr |
France | |
Service d'Oncologie Médicale et de Radiothérapie - Hôpital Saint André | Recruiting |
Bordeaux, France, 33075 | |
Contact: Alain Ravaud, Pr. 33 (0) 5 56 79 58 08 alain.ravaud@chu-bordeaux.fr | |
Sub-Investigator: Bogdan Catargi | |
Principal Investigator: Alain Ravaud | |
Département Endocrinolo-Dabéto-Nutrition - CHU d'Angers | Recruiting |
Angers, France, 49933 | |
Principal Investigator: Patrice Rodien | |
Centre Paul Papin | Not yet recruiting |
Angers, France, 49100 | |
Principal Investigator: Patrick Soulié | |
Service d'Endocrinologie et maladies métaboliques, Clinique Marc Linquette | Not yet recruiting |
Lille, France, 59037 | |
Principal Investigator: Jean-Louis Wemeau | |
Sub-Investigator: Christine Do Cao | |
Centre Léon Bérard | Recruiting |
Lyon, France, 69373 | |
Principal Investigator: Jean-Pierre Droz | |
Sub-Investigator: Christelle De la Fouchardière | |
Fédération Endocrinologie - Groupe Hopsitalier Est - Hôpital neurologique | Recruiting |
Bron, France, 69677 | |
Principal Investigator: Françoise Borson-Chazot | |
Sub-Investigator: Claire Bournaud | |
CRLC Val d'Aurelle | Recruiting |
Montpellier, France, 34298 | |
Principal Investigator: Stéphane Culine | |
Service de Cancérologie Médicale | Recruiting |
Paris, France, 75015 | |
Principal Investigator: Stéphane Oudard | |
Sub-Investigator: Florian Scotte | |
CHU de Nancy, Hôpital de Brabois | Recruiting |
Vandoeuvre les Nancy, France, 54511 | |
Principal Investigator: Marc Klein | |
Sub-Investigator: Laurence Choné | |
Service d'Endocrinologie - Hôpital de l'Archet I | Not yet recruiting |
Nice, France, 06202 | |
Principal Investigator: Jean-Louis Sadoul | |
Centre Antoine Lacassagne | Not yet recruiting |
Nice, France, 06189 | |
Principal Investigator: Marc Frenay | |
Service d'Oncologie Médicale, Institut Claudius Regaud | Recruiting |
Toulouse, France, 31052 | |
Principal Investigator: Jean-Pierre Delord | |
Sub-Investigator: Frédéric Courbon | |
Sub-Investigator: Marion Deslandres-Cruchant | |
Sub-Investigator: Slimane Zerdoud | |
Service d'endocrinologie et Maladies Métaboliques, Groupe Hospitalier Rangueil-Larrey CHU | Not yet recruiting |
Toulouse, France, 31059 | |
Principal Investigator: Philippe Caron | |
Service d'Endocrinologie, CHU Timone, AP-HM | Recruiting |
Marseille, France, 13385 | |
Principal Investigator: Patricia Nicolli-Sire | |
Service des Maladies Endocriniennes - Hôpital Lapeyronie | Recruiting |
Montpellier, France, 34295 | |
Principal Investigator: Jacques Bringer | |
Sub-Investigator: Eric Renard | |
Sub-Investigator: Isabelle Raingeard |
Principal Investigator: | Alain Ravaud, Pr. | University Hospital, Bordeaux, France |
Study Chair: | Geneviève Chene, Pr. | University Hospital, Bordeaux, France |
Study ID Numbers: | 9277-06, 2006-023 |
Study First Received: | August 1, 2007 |
Last Updated: | October 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00510640 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
thyroid carcinoma Sunitinib RECIST guidelines |
Thyroid Neoplasms Sunitinib Head and Neck Neoplasms Endocrine System Diseases Endocrinopathy |
Thyroid Diseases Endocrine Gland Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |