This study is an open-label, multicenter Phase II study of capivasertib administered orally in participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Capivasertib will be taken orally twice a day (BD) 4 days on/ 3 days off.
Research Site
Duarte, California, United States
Research Site
Los Angeles, California, United States
Research Site
Houston, Texas, United States
Objective Response Rate
Objective response rate is defined as the proportion of patients achieving either complete response (CR) or partial response (PR) according to the Lugano 2014 Classification for non-Hodgkin lymphoma (NHL) as assessed by blinded independent central review (BICR).
Time frame: First dose until progression of disease [PD] or last evaluable assessment in the absence of progression or data cut-off date (21.6 Months)
Duration of Response
Duration of response is defined as the time from the date of first documented response until date of documented progression according to the Lugano 2014 Classification for NHL as assessed by BICR, or death due to any cause.
Time frame: First documented response until date of documented progression or data-cut off date (21.6 Months)
Progression-free Survival
Progression-free survival is defined as the time from the date of first dose until documented disease progression according to the Lugano 2014 Classification for NHL as assessed by BICR, or death due to any cause. The analysis included all dosed patients, regardless of whether the patient withdrew from therapy, received another anti lymphoma therapy, or clinically progressed prior to progression according to the Lugano 2014 Classification for NHL.
Time frame: First dose until documented disease progression or data cut-off date (21.6 Months)
Overall Survival (OS)
Overall survival is defined as time from the date of first dose until the date of death due to any cause. The analysis included all dosed patients, regardless of whether the patient withdrew from therapy or received another anti lymphoma therapy. Patients who had not died by the analysis DCO date were censored at their last known date of being alive before the DCO date. Patients who were known to be alive or dead after the DCO date were censored at the DCO date. Patients who were lost to follow-up were censored at the date when they were last known to have been alive.
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Research Site
Victoria, British Columbia, Canada
Research Site
Aarhus N, Denmark
Research Site
Poitiers, France
Research Site
Villejuif, France
Research Site
Busan, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
...and 7 more locations
Time frame: First dose until data cut-off date (21.6 Months)
Number of Patients With Adverse Events and Serious Adverse Events
The safety and tolerability of the capivasertib treatment in each Cohort was assessed.
Time frame: Screening (Day -28 to -1) until Post-treatment follow-up up to 30 days after last dose or long-term follow-up or study completion (Every 12 weeks until death or lost to follow-up, unless patient have withdrawn consent [up to 21.6 Months])
Plasma Concentration of Capivasertib Overtime
The plasma concentration of capivasertib when administered in patients in each Cohort was determined.
Time frame: Cycle 1 (28-day treatment Cycle) Day 1 and on Cycle 1 Day 8, Cycle 1 Day 15 and Cycle 1 Day 22 (Pre-dose and post-dose)