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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00042666
First received: August 2, 2002
Last updated: October 16, 2009
Last verified: October 2009
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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
    Other Name: enzastaurin
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

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
Study First Received: August 2, 2002
Last Updated: October 16, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 22, 2014