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Idelalisib

An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

Ensayo de GILEAD SCIENCES, INC. en Leucemia linfocitica cronica · Linfoma no Hodgkin.

Más ensayos de: Leucemia linfocítica crónica · Linfoma no Hodgkin.

Fase

Fase 1/2

Estado

Interrumpido

Participantes

202

previstos

Centros

18

Fin del objetivo primario

jun 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2010.

Qué mide

Overall Response Rate (Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.

Más ensayos de GILD

Todos los de GILD, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01090414), actualizada en ago 2019.