Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088205
First received: July 22, 2004
Last updated: October 5, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
The purposes of this study are to determine the safety of oral enzastaurin HCl and any side effects that might be associated with it and whether enzastaurin HCl can help patients with Mantle Cell Lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle-Cell Lymphoma |
Drug: enzastaurin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2 Study of Oral Enzastaurin HCl in Patients With Relapsed Mantle Cell Lymphoma |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- To estimate the rate of freedom from progression for at least 3 cycles in patients with relapsed mantle cell lymphoma who have received enzastaurin. [ Time Frame: baseline, after 3 cycles ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To estimate the objective response rate (complete response [CR] plus unconfirmed complete response [CRu] plus partial response [PR]) [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- To estimate progression-free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
- Duration of overall response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
- Evaluate the impact and level of improvement with enzastaurin HCl as it pertains to B symptoms, tumor-related symptoms, patient functioning, quality of life, and overall health status using validated patient questionnaires [ Time Frame: baseline, cycle 2, 4 and 6 ] [ Designated as safety issue: No ]
- Assess PKC expression and Ki-67 expression by immunohistochemistry in mantle cell tumors from patients. [ Time Frame: baseline ] [ Designated as safety issue: No ]
- Evaluate the safety of enzastaurin HCl in this patient population [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
- Evaluate the pharmacokinetics of enzastaurin HCl using sparse sampling methodology in this population [ Time Frame: cycle 1, 2 and 3 ] [ Designated as safety issue: No ]
| Enrollment: | 61 |
| Study Start Date: | March 2004 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: enzastaurin
500 mg, oral, daily, up to six 28 day cycles
Other Name: LY317615
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mantle Cell Lymphoma
- Previous treatment for Mantle Cell Lymphoma
- Adequate organ function
Exclusion Criteria:
- Inability to swallow tablets
- Must not have had more than 3 prior treatments for Mantle Cell Lymphoma
- Must not have significant heart problems
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088205
Locations
| Australia, Queensland | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Woolloongabba, Queensland, Australia | |
| Australia, Victoria | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Parkville, Victoria, Australia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Prahran, Victoria, Australia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Wodonga, Victoria, Australia | |
| Australia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| East Melbourne, Australia | |
| France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Creteil Cedex, France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Lille, France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Nantes Cedex 1, France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Rouen Cedex, France | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Tours Cedex, France | |
| Germany | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Berlin, Germany | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Homburg Saar, Germany | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Kassel, Germany | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Koln, Germany | |
| Netherlands | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Groningen, Netherlands | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Nijmegen, Netherlands | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Rotterdam, Netherlands | |
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 to 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: | NCT00088205 History of Changes |
| Other Study ID Numbers: | 8360, H6Q-MC-JCAO |
| Study First Received: | July 22, 2004 |
| Last Updated: | October 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 23, 2013