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

Official Title

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)

Summary:

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).

Trial Description

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).

View this trial on ClinicalTrials.gov