A Study of Enzastaurin in Patients With Leukemia

Leukemia, Lymphocytic Clinical Trial

Official title:

A Phase 1b Pharmacokinetic-Pharmacodynamic-Pharmacogenomic Study of Enzastaurin in Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452257
• Other study ID #: 10724
• Secondary ID: H6Q-MC-S022
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2007
• Last updated: March 18, 2009
• Start date: May 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients are eligible to be included in the study only if they meet all of the following criteria:

1. Patients with B-cell CLL as diagnosed by expression of CD19, CD5, and CD23 by flow cytometry.

2. Rai Stage III or IV disease or earlier stage disease with indications for therapy per NCI Working Group criteria (Cheson et al. 1996)

3. Absolute lymphocyte count > or = to 5,000/microliter, with a lymphocyte WBC differential of > or = to 70%.

4. Platelet count >20,000/microliter.

5. 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:

1. Are unable to swallow tablets.

2. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.

3. Are pregnant or breastfeeding.

4. 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).

5. 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• enzastaurin
1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease

Locations

Country	Name	City	State
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chicago	Illinois
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Duarte	California
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Houston	Texas
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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells.		baseline, cycle 1, end of study	No
Secondary	Evaluation of activity of PKC beta in B-CLL cells		baseline, end of study	No
Secondary	Response rate		baseline to measured progressive disease	No
Secondary	Duration of response		time of response to progressive disease	No
Secondary	Time to progressive disease		baseline to measured progressive disease	No
Secondary	Safety		every cycle	Yes

External Links

•   Lilly Clinical Trial Registry