CAPITAL
Research type
Research Study
Full 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)
IRAS ID
1004171
Contact name
Michelle Beharry
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-000870-27
Research summary
AstraZeneca is sponsoring this study to learn more about the safety and efficacy of capivasertib (AZD5363), an experimental medication for patients with relapsed/refractory B-Cell non-Hodgkin lymphoma (NHL) and to better understand the disease and its associated health problems. NHL is the 7th most common cancer in the US and represents 4.3% of all new cancer cases. In 2020, there were an estimated 77,420 new cases of NHL, with a median age at diagnosis of 67 years, and an estimated 19,940 related deaths.
Capivasertib, blocks growth of cancer cells; it specifically blocks an enzyme (substance that brings about a biochemical change) called AKT, which is frequently reduced in cancer patients.
This study will also evaluate how capivasertib is taken up, broken down, distributed, and eliminated from the body. This is called pharmacokinetics. In addition, the effect of capivasertib on the body and on biomarkers (biological substances related to the disease or study medication) will be investigated.
Capivasertib has been tested in a large group of patients with various solid tumours (including breast and prostate cancer) and has shown an acceptable safety profile and positive outcome.
Study participants will receive capivasertib, an oral tablet, twice daily (morning and evening), 4 days on, 3 days off per week, every 28 days. The study is open label, which means the participants, study doctor, study staff, sponsor and sponsor representatives will be aware of the treatment received.
Depending on the type of lymphoma participants will be grouped into one of the following groups:
• Group A: follicular lymphoma.
• Group B: marginal zone lymphoma.
• Group C: mantle cell lymphoma.About 272 participants will take part in this study: Group A and Group B will include about 94 participants each; Group C will include about 84 participants.
This study will be conducted at approximately 28 study sites globally.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0322
Date of REC Opinion
30 Dec 2021
REC opinion
Further Information Favourable Opinion