Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma

Launched by NOVARTIS PHARMACEUTICALS · Jul 24, 2011

Keywords

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ALL

Eligibility criteria

• Inclusion Criteria:
• • Diffuse large B-cell lymphoma (DLBCL) with activating mutations in CD79 (A or B subunits). DLBCL that arose from transformed indolent lymphoma is allowed.
• • Prior treatment and relapse following anthracycline-based chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH alone. There is no limit to prior therapy allowed.
• • Patients may be treated with localized radiation to as many as two sites of disease, so long as measurable or evaluable disease remains at untreated sites.
• • Patients may be treated with corticosteriods immediately prior to enrollment and during the course of the study treatment as long as steriod treatment is tapered to a toal daily dosage of 10mg or less of prednisone (or it's equivalent) prior to AEB071 administration
• • WHO performance status of ≤2
• Exclusion Criteria:
• • Patients at screening who are treated with strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4) that can not be discontinued.
• * Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
• • History or presence of ventricular tachyarrhythmia
• • Presence of unstable atrial fibrillation (ventricular response \> 100 bpm); Patients with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria.
• • Angina pectoris or acute myocardial infarction ≤ 3 months prior to starting study drug
• • Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen)
• • Patients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinoma.
• • Patients with impairment of GI function or GI disease that could interfere with the absorption of AEB071.
• • Patients with a known history of Human Immunodeficiency Virus (HIV)
• • HIV testing is not required as part of this study
• • Patients with a known history of active hepatitis B or C infection unless they are on antiviral therapy
• • The determination of active hepatitis status should be as per standard of care at each site
• • Hepatitis B and C testing is not required as part of this study
• Time since the last prior therapy for treatment of underlying malignancy\*\*:
• • Cytotoxic chemotherapy: ≤ than the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all)
• • Biologic therapy (e.g., antibodies): ≤ 4 weeks
• • ≤ 5 x t1/2 of a small molecule therapeutic, not otherwise defined above
• • \*\*Patients must have recovered or stabilized from all toxicities related to their previous treatment except for alopecia
• • Patients with any history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation that would interfere with biopsies.
• • Patients having undergone major surgery less than 4 weeks prior to enrollment or that have not fully recovered from prior surgery.
• • Pregnant or nursing (lactating) women
• • Other protocol-defined inclusion/exclusion criteria may apply