Ensayos clínicos

Study closed to enrollment

Inclusion Criteria:

• Male or female patients age 18 or older
• Patients with PTCL according to World Health Organization (WHO) criteria and have relapsed or are refractory to at least 1 prior systemic, cytoxic therapy for PTCL. Patients must have received conventional therapy as a prior therapy. Cutaneous-only disease is no permitted. Patients must have documented evidence of progressive disease.
• Tumor biopsy available for central hematopathologic review
• Measurable disease according to the IWG criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse.
• Male patients who agree to practice effective barrier contraception through 6 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
• Suitable venous access
• Voluntary written consent

Exclusion Criteria

• Known central nervous system lymphoma
• Systemic antineoplastic therapy, immunotherapy, investigational agent or radiation therapy within 4 weeks of first dose of study treatment or concomitant use during study
• Prior administration of an Aurora A kinase-targeted agent, including alisertib; or all of the 3 comparator drugs (pralatrexate, or romidepsin or gemcitabine; or known hypersensitivity)
• History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
• Cardiac condition as specified in study protocol, including left ventricular ejection fraction (LVEF) <40%
• Concomitant use of other medicines as specified in study protocol
• Patients with abnormal gastric or bowel function who require continuous treatment with H2-receptor antagonists or proton pump inhibitors
• Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
• Autologous stem cell transplant less than 3 months prior to enrollment
• Patients who have undergone allogeneic stem cell or organ transplantation any time
• Inadequate blood levels, bone marrow or other organ function as specified in study protocol
• The patient must have recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 toxicity, to patients's baseline status (except alopecia), or deemed irreversible from the effects of prior cancer therapy
• Major surgery, serious infection, or infection requiring systemic antibiotic therapy within 14 days prior to the first dose of study treatment
• Female patients who are breastfeeding or pregnant
• Coexistent second malignancy or history of prior solid organ malignancy within previous 3 years
• Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol