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

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).


Condition Intervention Phase
Non-Hodgkin's Lymphoma
 Drug: LY317615
 Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 2 Evaluation of Oral LY317615 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
Drug Information available for: Enzastaurin
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: June 2002
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: LY317615
    500 mg, oral, daily, up to six 28 day cycles
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042666

Locations
United States, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Royal Oak, Michigan, United States
United States, Minnesota
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Minneapolis, Minnesota, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rochester, Minnesota, United States
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 4849, H6Q-MC-JCAI
Study First Received: August 2, 2002
Last Updated: October 16, 2009
ClinicalTrials.gov Identifier: NCT00042666     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
 Neoplasms by Histologic Type
Immune System Diseases
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 30, 2009



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