A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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
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 May 16, 2013