Date: 2013-05-16
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: AstraZeneca (UK)
Product: moxetumomab pasudotox
Action
mechanism: antibody drug conjugate. Moxetumomab pasudotox is a CD22 immunotoxin composed of a binding portion of an anti-CD22 antibody fused to a toxin. After binding to CD22, the molecule is internalised, processed and releases its modified protein toxin that inhibits protein translation, leading to tumour cell death.
Disease: unresponsive or relapsed hairy cell leukaemia
Therapeutic area: Cancer - Oncology
Country: Belgium, Canada, Czech Republic, France, Germany, Ireland, Israel, Italy, Norway, Poland, Serbia, Spain, UK, USA
Trial
details: Moxetumomab pasudotox is an investigational cancer treatment that has been tested in Phase I in people with hairy cell leukaemia. The Phase I study showed significant response rates for moxetumomab pasudotox in the hairy cell leukaemia population with a manageable safety profile, accelerating this program into a Phase III registration trial. The primary endpoint of the Phase III trial will be to measure the rate of durable complete response in patients treated with moxetumomab pasudotox as a 40mcg/kg intravenous infusion delivered over 30 minutes on days 1, 3, 5 of each 28-day cycle until complete response, progressive disease, initiation of alternate cancer therapy, or unacceptable toxicity. Secondary endpoints include overall response rate, relapse-free survival and progression-free survival. (NCT01829711)
Latest
news: * On May 16, 2013, AstraZeneca has announced that the first patient has been enrolled in Phase III clinical trial for moxetumomab pasudotox as a treatment for unresponsive or relapsed hairy cell leukaemia patients. The trial is sponsored by the Cancer Therapy Evaluation Program (CTEP), a programme within the Division of Cancer Treatment and Diagnosis at the US National Cancer Institute, and will evaluate moxetumomab pasudotox as a potential treatment in adult patients with hairy cell leukaemia who have not responded to or relapsed after standard therapy.
