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A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
T-Cell Lymphoma, B-Cell Lymphoma

Thank you

Trial Information

A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas


Inclusion Criteria:



- Have measurable lesions

- Have recovered from prior chemotherapies

- Have an estimated life expectancy of at least 12 weeks

- Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal
to 2.0 x ULN (less than 5x if liver metastases are present)

- Renal: serum creatinine less than or equal to 1.5XULN

- Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /L,
absolute neutrophil count (ANC) greater than or equal to 1.0 x 09 /L

Exclusion Criteria:

- Have a second primary malignancy (except adequately treated nonmelanomatous skin
cancer, or other cancer that is considered cured by surgical resection or radiation).

- Anti-lymphoma therapy within the past 3 weeks

- Unable to swallow tablets

- Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14
days prior to study enrollment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

11503

NCT ID:

NCT00542919

Start Date:

November 2007

Completion Date:

February 2014

Related Keywords:

  • T-Cell Lymphoma
  • B-Cell Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, T-Cell

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904