Brief Title
A Study for Patients With Non-Hodgkin's Lymphomas
Official Title
A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas
Brief Summary
In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes: - T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL) - Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma - Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])
Secondary Outcome
Progression Free Survival (PFS)
Condition
T-Cell Lymphoma
Intervention
enzastaurin
Study Arms / Comparison Groups
T-Cell
Description: T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
57
Start Date
November 2007
Completion Date
February 27, 2018
Primary Completion Date
March 2010
Eligibility Criteria
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 /Liter (L) 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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), ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00542919
Organization ID
11503
Secondary IDs
H6Q-MC-S057
Responsible Party
Sponsor
Study Sponsor
Eli Lilly and Company
Study Sponsor
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), Study Director, Eli Lilly and Company
Verification Date
September 2020