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

Completed · Phase 2

Conditions studied: Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

In brief

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).

Key facts

Study ID: NCT05008055
Run by: AstraZeneca
People needed: 30
Starts: 2021-11-03
Expected to finish: 2024-10-25
Last updated by the study team: 2024-12-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

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
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

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
Additional exclusion core criteria may apply, please refer to the protocol
Module 1 specific exclusion criteria:
Follicular lymphoma grade 3B
Known transformation to aggressive lymphoma, eg, large cell lymphoma
Participants who, in the Investigator's opinion, require immediate cytoreductive therapy for disease control

Where it is running

Research Site — Duarte, California, United States
Research Site — Los Angeles, California, United States
Research Site — Houston, Texas, United States
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
Research Site — Badalona, Spain
Research Site — Barcelona, Spain
Research Site — Madrid, Spain
Research Site — Madrid, Spain
Research Site — Cambridge, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Sutton, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.