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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


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
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Active, not recruiting NCT00315419 - Identifying Characteristics of Bone Marrow Failure Syndromes N/A
Active, not recruiting NCT03792256 - Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) Phase 1

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