Status:
COMPLETED
Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma. The trial did not progress into Phase II due to the suboptimal tol...
Detailed Description
This is a Phase Ib dose escalation and Phase II study in patients with DLBCL harboring mutations in CD79A/B or of the ABC subtype. Pre-screening for mutations in CD79A/B or the ABC subtype will be req...
Eligibility Criteria
Inclusion
- Male or female ≥18 years of age.
- Diffuse DLBCL with activating mutations in CD79 (A or B subunits) or ABC-subtype DLBCL (CD79 wildtype or CD79 mutant). DLBCL that arose from transformed indolent lymphoma is allowed.
- Prior treatment and relapse following chemotherapy and autologous bone marrow or stem cell transplant. Patients who are not transplant eligible or who did not respond to chemotherapy may be considered for the study following a single regimen of chemotherapy such as R-CHOP or R-EPOCH. There is no limit to number of prior therapies allowed.
- May be treated with localized radiation as long as measurable or evaluable disease remains at untreated sites.
- WHO performance status of ≤ 2.
- A representative FFPE tumor sample must be available for molecular testing along with a corresponding pathology report. An archival tumor sample may be submitted. However, if not available, a new tumor biopsy obtained for the purpose of this study must be submitted instead.
Exclusion
- Treatment with strong inducers or inhibitors (medications and herbal supplements) of cytochrome P450 3A4/5 (CYP3A4/5), or CYP3A4/5 substrates with a QT prolongation risk that cannot be discontinued at least 7 half-lives (or if the half-life is unknown,14 days) prior to study drug treatment.
- Impaired cardiac function or clinically significant cardiac diseases.
- Impairment of GI function or GI disease that could interfere with the absorption of AEB071 or everolimus.
- Severe systemic infections, current or within the two weeks prior to initiation of AEB071.
- Kown history of HIV.
- Poorly controlled diabetes as defined by a fasting serum glucose \> 2.0 x ULN.
- Evidence of current CNS involvement.
- Significant symptomatic deterioration of lung function.
Key Trial Info
Start Date :
December 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01854606
Start Date
December 5 2013
End Date
June 1 2016
Last Update
December 19 2020
Active Locations (15)
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1
Washington University School of Medicine Dept of Oncology.
St Louis, Missouri, United States, 63110
2
Memorial Sloan Kettering Cancer Center Onc. Dept.
New York, New York, United States, 10065
3
Sarah Cannon Research Institute Dept of Onc
Nashville, Tennessee, United States, 37203
4
Novartis Investigative Site
Rouen, France, 76038