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A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
This study has been completed.
Study NCT00042666   Information provided by Eli Lilly and Company
First Received: August 2, 2002   Last Updated: October 16, 2009   History of Changes

August 2, 2002
October 16, 2009
June 2002
September 2008   (final data collection date for primary outcome measure)
Estimate the clinical response rate in patients with relapsed or refractory DLBCL who have received LY317615 [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Estimate the clinical response rate in patients with relapsed or refractory DLBCL who have received LY317615
Complete list of historical versions of study NCT00042666 on ClinicalTrials.gov Archive Site
  • Estimate objective response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Measure progression free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of overall response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Evaluate safety of LY317615 in this population [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Evaluate population pharmacokinetics [ Time Frame: cycle 1, day 1 and 28 ] [ Designated as safety issue: No ]
  • Assess PKC beta expression by immunohistochemistry in readily assessable DLBCL tumors from patients [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • -Estimate objective response rate
  • -Measure progression free survival and duration of overall response
  • -Evaluate safety of LY317615 in this population
  • -Evaluate population pharmacokinetics
  • -Assess PKC beta expression by immunohistochemistry in readily assessable DLBCL tumors from patients
  • -Evaluate clinical efficacy of LY317615 as it pertains to B-symptoms and or other tumor related symptoms
 
A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
A Phase 2 Evaluation of Oral LY317615 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study will measure the effectiveness and any side effects of LY317615 in patients with Diffuse large B-cell lymphoma (a sub-type of Non-Hodgkins Lymphoma).
 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Non-Hodgkin's Lymphoma
Drug: LY317615
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
55
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of recurrent or refractory Diffuse B-cell Non-Hodgkin's lymphoma.
  • Adequate organ functions.
  • Able to swallow capsules.

Exclusion Criteria:

  • More than 3 prior treatments for this disease.
  • Serious heart problems.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00042666
Chief Medical Officer, Eli Lilly
4849, H6Q-MC-JCAI
Eli Lilly and Company
 
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP




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