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A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.

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ClinicalTrials.gov Identifier: NCT00042666
Recruitment Status : Completed
First Posted : August 6, 2002
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: LY317615 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Evaluation of Oral LY317615 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Study Start Date : June 2002
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma


Intervention Details:
  • Drug: LY317615
    500 mg, oral, daily, up to six 28 day cycles
    Other Name: enzastaurin


Primary Outcome Measures :
  1. Estimate the clinical response rate in patients with relapsed or refractory DLBCL who have received LY317615 [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures :
  1. Estimate objective response rate [ Time Frame: baseline to measured progressive disease ]
  2. Measure progression free survival [ Time Frame: baseline to measured progressive disease ]
  3. Duration of overall response [ Time Frame: time of response to progressive disease ]
  4. Evaluate safety of LY317615 in this population [ Time Frame: every cycle ]
  5. Evaluate population pharmacokinetics [ Time Frame: cycle 1, day 1 and 28 ]
  6. Assess PKC beta expression by immunohistochemistry in readily assessable DLBCL tumors from patients [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00042666     History of Changes
Obsolete Identifiers: NCT00054080
Other Study ID Numbers: 4849
H6Q-MC-JCAI
First Posted: August 6, 2002    Key Record Dates
Last Update Posted: October 19, 2009
Last Verified: October 2009

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