Back to resultsA Study of Enzastaurin in Patients With Leukemia
Primary Purpose
Leukemia, Lymphocytic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
enzastaurin
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic
Eligibility Criteria
Inclusion Criteria:
Patients are eligible to be included in the study only if they meet all of the following criteria:
- Patients with B-cell CLL as diagnosed by expression of CD19, CD5, and CD23 by flow cytometry.
- Rai Stage III or IV disease or earlier stage disease with indications for therapy per NCI Working Group criteria (Cheson et al. 1996)
- Absolute lymphocyte count > or = to 5,000/microliter, with a lymphocyte WBC differential of > or = to 70%.
- Platelet count >20,000/microliter.
Adequate organ function, including the following:
- Hepatic: bilirubin < or = to 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = to 2.5 x ULN
- Renal: serum creatinine < or = to 1.5 X ULN.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
- Are unable to swallow tablets.
- Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
- Are pregnant or breastfeeding.
- Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy).
- Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells.
Secondary Outcome Measures
Evaluation of activity of PKC beta in B-CLL cells
Response rate
Duration of response
Time to progressive disease
Safety
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452257
Brief Title
A Study of Enzastaurin in Patients With Leukemia
Official Title
A Phase 1b Pharmacokinetic-Pharmacodynamic-Pharmacogenomic Study of Enzastaurin in Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to see if enzastaurin affects the pGSK3 beta level in B-cell chronic lymphocytic leukemia (B-CLL) cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
enzastaurin
Other Intervention Name(s)
LY317615
Intervention Description
1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease
Primary Outcome Measure Information:
Title
To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells.
Time Frame
baseline, cycle 1, end of study
Secondary Outcome Measure Information:
Title
Evaluation of activity of PKC beta in B-CLL cells
Time Frame
baseline, end of study
Title
Response rate
Time Frame
baseline to measured progressive disease
Title
Duration of response
Time Frame
time of response to progressive disease
Title
Time to progressive disease
Time Frame
baseline to measured progressive disease
Title
Safety
Time Frame
every cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients are eligible to be included in the study only if they meet all of the following criteria:
Patients with B-cell CLL as diagnosed by expression of CD19, CD5, and CD23 by flow cytometry.
Rai Stage III or IV disease or earlier stage disease with indications for therapy per NCI Working Group criteria (Cheson et al. 1996)
Absolute lymphocyte count > or = to 5,000/microliter, with a lymphocyte WBC differential of > or = to 70%.
Platelet count >20,000/microliter.
Adequate organ function, including the following:
Hepatic: bilirubin < or = to 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) < or = to 2.5 x ULN
Renal: serum creatinine < or = to 1.5 X ULN.
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
Are unable to swallow tablets.
Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
Are pregnant or breastfeeding.
Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off of corticosteroids for at least 4 weeks before starting study therapy).
Have a serious concomitant systemic disorder (including active bacterial, fungal, or viral infection) that, in the opinion of the investigator, would compromise the patient's ability to adhere to the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5 PM Eastern Time (UTC/GMT- 5 hours,EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Enzastaurin in Patients With Leukemia
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