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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphocytic

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells.

Outcome Time Frame:

baseline, cycle 1, end of study

Safety Issue:

No

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

10724

NCT ID:

NCT00452257

Start Date:

May 2007

Completion Date:

September 2008

Related Keywords:

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

Name

Location

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.Manhassaet, New York  
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.Greenbrae, California  94904
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  60674
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.Bedford, Texas  76022