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Milciclib maleate

Study of Milciclib in Patients With Unresectable/Metastatic Hepatocellular Carcinoma

Ensayo de Tiziana Life Sciences Ltd en Carcinoma hepatocelular.

Más ensayos de: Carcinoma hepatocelular.

Fase

Fase 2

Estado

Completado

Participantes

31

previstos

Centros

14

Fin del objetivo primario

may 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jul 2017.

Qué mide

Overall Safety Profile (From Informed Consent signature to 30 days after last dose intake up to Day 180 from treatment start) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary aim of this exploratory study is to test the safety and tolerability of milciclib when administered orally at 100 mg in patients with recurrent or metastatic Hepatocellular Carcinoma. The evaluation of the efficacy profile is a secondary objective of the study. Moreover, markers expression in tumor cells and plasma will be studied and described in association with the clinical outcome. Eligible patients will receive milciclib orally on a daily schedule for 4 consecutive days a week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3 cycles) unless patient refusal, consent withdrawal, Investigator's decision, unacceptable toxicity or death whichever occurs earlier. At the end of Cycle 3, treatment will be stopped, and based on the results of the tumor assessment performed on Day 90 (±3 days) from treatment start, patients will be followed as here below detailed: * patients with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) will be followed for safety until 30 days from last dose intake (or until a new anticancer therapy starts, whichever occurs earlier) and will be assessed for efficacy in the follow-up period up to Day 180 from treatment start; * patients with progressive disease will be followed only for safety until 30 days from last dose intake (or until a new anticancer therapy starts, whichever occurs earlier). After the completion of three cycles, patients who, in the Investigator's judgment, are benefiting from treatment with milciclib, will resume treatment and will remain on study up to Day 180 from treatment start, unless withdrawal criteria are met earlier.

Más ensayos de TLSA

Todos los de TLSA, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03109886), actualizada en oct 2021.