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An Open-Label, Single-arm, Phase I Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Diffuse Large B-Cell Lymphoma

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Trial Information

An Open-Label, Single-arm, Phase I Study of AEB071 (a Protein Kinase C Inhibitor) in Patients With CD79-mutant Diffuse Large B-Cell Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Frequency of Dose Limiting Toxicity (DLT) during cycle 1 (Dose Escalation phase)

Outcome Time Frame:

Cycle 1 (28 days)

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

COEB071X2101

NCT ID:

NCT01402440

Start Date:

November 2011

Completion Date:

July 2014

Related Keywords:

  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma,
  • Phase 1,
  • CD79 Mutation
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

City of Hope National Medical CenterLos Angeles, California  91010
Washington University School Of Medicine-Siteman Cancer Ctr Div. of Medical OncologySt. Louis, Missouri  63110
Hackensack University Medical Center Hackensack (SC)Hackensack, New Jersey  07601
Memorial Sloan Kettering Cancer Center MSK 2New York, New York  10021
Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio StateColumbus, Ohio  43210
MD Anderson Cancer Center/University of Texas SC LocationHouston, Texas  77030-4009