Status:
TERMINATED
Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study has two phases, a dose escalation phase and a dose expansion phase. For dose escalation, the primary objective is to estimate the maximum tolerated dose of AEB071 in patients with diffuse l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01402440
Start Date
November 1 2011
End Date
April 1 2014
Last Update
December 19 2020
Active Locations (24)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
2
Washington University School of Medicine Div. of Medical Oncology
St Louis, Missouri, United States, 63110
3
Hackensack University Medical Center Hackensack (SC)
Hackensack, New Jersey, United States, 07601
4
Memorial Sloan Kettering Cancer Center MSK 2
New York, New York, United States, 10021