Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
CAPITAL
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)
2 other identifiers
interventional
30
7 countries
17
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2021
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 17, 2021
CompletedStudy Start
First participant enrolled
November 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2023
CompletedResults Posted
Study results publicly available
June 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2024
CompletedDecember 20, 2024
November 1, 2024
1.8 years
July 19, 2021
May 6, 2024
November 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
First dose until progression of disease [PD] or last evaluable assessment in the absence of progression or data cut-off date (21.6 Months)
Secondary Outcomes (5)
Duration of Response
First documented response until date of documented progression or data-cut off date (21.6 Months)
Progression-free Survival
First dose until documented disease progression or data cut-off date (21.6 Months)
Overall Survival (OS)
First dose until data cut-off date (21.6 Months)
Number of Patients With Adverse Events and Serious Adverse Events
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
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)
Study Arms (1)
Capivasertib monotherapy
EXPERIMENTALParticipants with R/R FL, R/R MZL, and R/R MCL will receive capivasertib orally until progression of disease (PD) or unacceptable toxicity.
Interventions
Capivasertib will be taken orally twice a day (BD) 4 days on/ 3 days off.
Eligibility Criteria
You may qualify if:
- Participants must be ≥ 18 years of age, at the time of signing the informed consent
- Eastern Cooperative Oncology Group performance status ≤ 2
- Life expectancy \> 6 months
- Female participants must not be breast-feeding and must have a negative pregnancy test (serum) prior to start of dosing
- Histologically confirmed diagnosis of FL Grade 1, 2, or 3a as assessed by investigator or local pathologist
- Current need for systemic treatment based on the Investigator's opinion
- Relapsed, progressed or refractory (defined as failure to achieve at least a partial response \[PR\]) after at least 2 prior systemic lines of therapy (including anti-CD20 monoclonal antibody \[mAb\] and an alkylating agent)
- Bi-dimensionally measurable disease on cross sectional imaging by computed tomography (CT) or magnetic resonance imaging (MRI) with at least one nodal lesion \> 1.5 cm in the long axis or at least one extranodal lesion \> 1 cm in long axis.
- Histologically confirmed MZL including splenic, nodal, and extranodal subtypes as assessed by investigator or local pathologist
- Current need for systemic treatment based on the Investigator's opinion
- Relapsed, progressed or refractory (defined as failure to achieve at least a PR) after at least 2 prior systemic lines of therapy (including at least one anti-CD20mAb directed regimen either as monotherapy or as chemoimmunotherapy; Helicobacter pylori eradication and radiation therapy alone will not be considered a systemic treatment regimen)
- Bi-dimensionally measurable disease on cross sectional imaging by CT or MRI with at least one nodal lesion \> 1.5 cm in the long axis or at least one extranodal lesion \> 1 cm in long axis
- Histologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1, as assessed by investigator or local pathologist
- Relapsed, progressed or refractory (defined as failure to achieve at least a PR) after at least 2 prior systemic lines of therapy
- Participants must have received as prior therapies
- +4 more criteria
You may not qualify if:
- Prior malignancy (other than the disease under study), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the participant has been disease free for ≥ 2 years
- With the exception of alopecia, any unresolved non-haematological toxicities from prior therapy ≥ Common Terminology Criteria for Adverse Events Grade 2 at the time of starting study treatment
- Known medically apparent central nervous system lymphoma or leptomeningeal disease
- Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values at screening:
- Absolute neutrophil count \< 1.0 × 10\^9/L; \< 0.75 × 10\^9/L in participants with known bone marrow involvement of malignant disease
- Platelets \< 75 × 10\^9/L; \< 50 × 10\^9/L in participants with known bone marrow involvement of malignant disease
- Creatinine clearance \< 50 mL/min per the Cockcroft and Gault formula
- Clinically significant abnormalities of glucose metabolism as participants with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment and Glycosylated haemoglobin ≥ 8.0% (63.9 mmol/mol)
- Prior treatment with any of the following:
- Any investigational agents or study drugs from a previous clinical study within 5 half lives or 2 weeks from the first dose of capivasertib in this study
- Strong inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or drugs that are sensitive to inhibition of CYP3A4 within 1 week prior to the first dose of study treatment
- Prior allogenic Haematopoietic stem cell transplant (HSCT) within 6 months from the first dose of capivasertib (patients \> 6 months after allogenic HSCT are eligible in the absence of active graft-versus-host disease and concomitant immune suppressive therapy). Prior cellular therapies (eg, Chimeric antigen receptor T therapy) and/or autologous HSCT within 3 months from the first dose of capivasertib
- Receipt of live, attenuated vaccine within 28 days before the first dose of study treatment(s)
- Participants who, due to other medical conditions /prior history /concomitant medications are, in the investigator's opinion, at a risk of a venous thromboembolism (VTE) and are not willing to accept the VTE prophylaxis, will be excluded. The initiation of an adequate VTE prophylaxis will be based on treating physician risk/benefit assessment and in agreement with the local management guidelines
- Follicular lymphoma grade 3B
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (17)
Research Site
Duarte, California, 91010, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Victoria, British Columbia, V8R 6V5, Canada
Research Site
Aarhus N, DK8200, Denmark
Research Site
Poitiers, 86021, France
Research Site
Villejuif, 94805, France
Research Site
Busan, 49241, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 3722, South Korea
Research Site
Badalona, 08003, Spain
Research Site
Barcelona, 8035, Spain
Research Site
Madrid, 28040, Spain
Research Site
Madrid, 28046, Spain
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Research Site
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2021
First Posted
August 17, 2021
Study Start
November 3, 2021
Primary Completion
August 22, 2023
Study Completion
October 25, 2024
Last Updated
December 20, 2024
Results First Posted
June 20, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.