Calendario›EXEL›rosiglitazone
rosiglitazone
A Drug-Drug Interaction Study of the Effects of XL184 (Cabozantinib) on Rosiglitazone in Subjects With Solid Tumors
Ensayo de EXELIXIS, INC. en Papillary Thyroid Cancer · Follicular Thyroid Cancer · Huerthle Cell Thyroid Cancer · Renal Cell Carcinoma (del registro, en inglés).
Más ensayos de: Carcinoma de células renales.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 40
- Centros
- 5
- Fin del objetivo primario
- ago 2012
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2010.
Qué mide
Pharmacokinetics of XL184 and rosiglitazone (at weekly or twice-weekly visits for the first 4 weeks) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe primary objective of this clinical study is to determine whether the inhibition of cytochrome P450 (CYP) isozyme CYP2C8 by XL184 observed in in vitro preclinical studies translates into the potential for clinically significant drug-drug interactions in humans. The study will measure the effect of once daily dosing of XL184 on the pharmacokinetics (PK) of rosiglitazone. The PK of XL184 when combined with rosiglitazone will be evaluated as well. A specific objective of this study is to determine whether the interaction between XL184 and a drug such as rosiglitazone is sufficiently large enough to necessitate a dosage adjustment when used in combination with XL184, or whether the interaction would require additional therapeutic monitoring. Rosiglitazone, commonly known as Avandia, is a prescription medicine approved by the FDA used to treat adults with Type 2 (adult-onset or non-insulin dependent) diabetes mellitus (high blood sugar). In this study, subjects will only take 2 doses of rosiglitazone. There is no intention of therapy as a result of taking rosiglitazone in this study.
Más ensayos de EXEL
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Cabozantinib · EXAMINER | Fase 4 | En marcha, sin reclutar | jul 2020 (real) |
| Cabozantinib | Fase 3 | En marcha, sin reclutar | ago 2020 (real) |
| Cabozantinib · COSMIC-312 | Fase 3 | En marcha, sin reclutar | nov 2021 (real) |
| Cabozantinib · COSMIC-313 | Fase 3 | En marcha, sin reclutar | ene 2022 (real) |
| cabozantinib | Fase 1 | En marcha, sin reclutar | feb 2023 (real) |
| Cabozantinib · CONTACT-02 | Fase 3 | En marcha, sin reclutar | abr 2024 (real) |
Todos los de EXEL, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01100619), actualizada en sep 2013.