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Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

NCT ID: NCT01854606

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-05

Study Completion Date

2016-06-01

Brief Summary

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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 tolerability of the combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There were no serious safety concerns associated with this combination.

Detailed Description

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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 required, as it is anticipated that both patient groups may receive clinical benefit from the combination of AEB071 and EVEROLIMUS.

Conditions

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CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma

Keywords

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Diffuse Large B-Cell Lymphoma, DBCL, AEB071, Everolimus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AEB071 and EVEROLIMUS

AEB071 and EVEROLIMUS will be taken together in this open-label non-randomized study

Group Type EXPERIMENTAL

AEB071

Intervention Type DRUG

a Protein Kinase C Inhibitor

Everolimus

Intervention Type DRUG

mTOR inhibitor

Interventions

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AEB071

a Protein Kinase C Inhibitor

Intervention Type DRUG

Everolimus

mTOR inhibitor

Intervention Type DRUG

Other Intervention Names

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sotrastuarin RAD001

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Washington University School of Medicine Dept of Oncology.

St Louis, Missouri, United States

Site Status

Memorial Sloan Kettering Cancer Center Onc. Dept.

New York, New York, United States

Site Status

Sarah Cannon Research Institute Dept of Onc

Nashville, Tennessee, United States

Site Status

Novartis Investigative Site

Rouen, , France

Site Status

Novartis Investigative Site

Mainz, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

New Territories, Hong Kong, Hong Kong

Site Status

Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Milan, MI, Italy

Site Status

Novartis Investigative Site

Rotterdam, , Netherlands

Site Status

Novartis Investigative Site

Rotterdam, , Netherlands

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Seoul, Korea, South Korea

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Countries

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Czechia United Kingdom United States France Germany Hong Kong Italy Netherlands South Korea Taiwan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=16288

Results for COEB071X2103 from the Novartis Clinical Trials website

Other Identifiers

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COEB071X2103

Identifier Type: -

Identifier Source: org_study_id