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)

Who is this study for? Patients with relapsed or refractory B-cell non-Hodgkin lymphoma
What treatments are being studied? Capivasertib
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: No
View:

• 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

• Module 1 specific inclusion criteria:

• Additional Inclusion Criteria for Cohort 1A (R/R FL):

• 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.

• Additional Inclusion Criteria for Cohort 1B (R/R MZL):

• 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

• Additional Inclusion Criteria for Cohort 1C (R/R MCL):

• 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

• Prior regimens must have included:

• BTK inhibitor and

• Anti-CD20mAb therapy

• 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

Locations
United States
California
Research Site
Recruiting
Duarte
Research Site
Recruiting
Los Angeles
Georgia
Research Site
Withdrawn
Atlanta
Texas
Research Site
Recruiting
Dallas
Research Site
Recruiting
Houston
Other Locations
Canada
Research Site
Not yet recruiting
Toronto
Research Site
Recruiting
Victoria
Denmark
Research Site
Not yet recruiting
Aarhus N
Research Site
Recruiting
Roskilde
France
Research Site
Recruiting
La Tronche
Research Site
Recruiting
Lille Cedex
Research Site
Recruiting
Poitiers
Research Site
Recruiting
Villejuif
Republic of Korea
Research Site
Recruiting
Busan
Research Site
Recruiting
Seoul
Research Site
Recruiting
Seoul
Research Site
Recruiting
Seoul
Research Site
Recruiting
Seoul
Spain
Research Site
Recruiting
Badalona
Research Site
Recruiting
Barcelona
Research Site
Recruiting
Madrid
Research Site
Recruiting
Madrid
Research Site
Recruiting
Salamanca
United Kingdom
Research Site
Recruiting
Cambridge
Research Site
Not yet recruiting
Glasgow
Research Site
Withdrawn
Hampshire
Research Site
Not yet recruiting
London
Research Site
Recruiting
Manchester
Research Site
Not yet recruiting
Oxford
Research Site
Not yet recruiting
Plymouth
Research Site
Not yet recruiting
Sutton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: November 3, 2021
Estimated Completion Date: November 2, 2023
Participants
Target number of participants: 272
Treatments
Experimental: Capivasertib monotherapy
Participants with R/R FL, R/R MZL, and R/R MCL will receive capivasertib orally until progression of disease (PD) or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Collaborators: Parexel
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov