Alisertib vs pralatrexate or gemcitabine Phase III open label study
Research type
Research Study
Full title
A Phase 3, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator’s Choice (Selected Single Agent) in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma
IRAS ID
103218
Contact name
Eve Gallop-Evans
Sponsor organisation
Millennium Pharmaceuticals, Inc
Eudract number
2011-003545-18
Clinicaltrials.gov Identifier
Research summary
phase 3 open-label (both patients and study doctor/team know which treatment is given/taken) study done to find out whether alisertib is more effective than pralatrexate or gemcitabine when given to patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL).Alisertib has been developed to interfere with cell division which is required for normal and cancer cell growth. When a single cell divides into two new cells, its chromosomes (genetic material) must be divided equally between the cells. Aurora A kinase is the enzyme that controls the distribution of the new chromosomes into each of the new cells. Alisertib works by blocking Aurora A kinase. The blocking of Aurora A kinase may interfere with dividing cells, thereby, slowing cancer growth and causing cancer cell death. Pralaxelate is approved for sale in the USA by the Food and Drug Administration(FDA) as PTCL treatment in patients with disease progression following at least one prior treatment. Gemcitabine is not approved for the treatment of PTCL by the FDA,but is active in this type of lymphoma. Up to 354 patients at about 140 sites worldwide will participate in this study. Male and/or female patients 18= years of age with PTCL, who have not responded to at least one prior treatment or for whom the treatment is no longer effective, may be eligible to participate in this study. Eligible patients will be randomly assigned (like the flip of a coin) to receive alisertib (Arm A) or either pralatrexate or gemcitabine (Arm B). The study doctor will be able to choose either pralatrexate or gemcitabine for patients in Arm B as long as the patient has not received the drug previously. The study is expected to last approximately 54 months. Patients will be followed for survival for 2years from date of last patient off treatment or death, whichever occurs first.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
12/EM/0167
Date of REC Opinion
22 Jun 2012
REC opinion
Further Information Favourable Opinion