Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Titre officiel

A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)

Sommaire:

This study is an open-label, multicentre Phase II study of capivasertib administered orally in participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

Description de l'essai

Primary Outcome:

  • Proportion of participants with objective response
Secondary Outcome:
  • Duration of response (DoR)
  • Progression-free survival
  • Overall survival (OS)
  • Change from baseline in health-related quality of life as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
  • Proportion of participants reporting symptomatic adverse events (AEs) and overall side effect burden at each time point as measured by Patient Global Impression of Treatment Tolerability (PGI-TT)
  • Change in National Cancer Institute patient-reported outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) symptoms
  • Time to first subsequent therapy or death (TFST)
  • Time to objective response (TTR)
  • Number of participants with AEs and Serious adverse events
  • Observed lowest drug concentration reached before the next dose is administered (Ctrough) of capivasertib
  • Plasma concentration of capivasertib post-dose
The study protocol follows a modular design. The study will investigate the safety and efficacy of capivasertib monotherapy in participants with R/R Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL).

Voir cet essai sur ClinicalTrials.gov

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