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A Study of Enzastaurin in Patients With Leukemia

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00452257
Collaborator
(none)
18
Enrollment
4
Locations
1
Arm
16.1
Duration (Months)
4.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Pharmacokinetic-Pharmacodynamic-Pharmacogenomic Study of Enzastaurin in Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL)
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease
Other Names:
  • LY317615

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells. [baseline, cycle 1, end of study]

    Secondary Outcome Measures

    1. Evaluation of activity of PKC beta in B-CLL cells [baseline, end of study]

    2. Response rate [baseline to measured progressive disease]

    3. Duration of response [time of response to progressive disease]

    4. Time to progressive disease [baseline to measured progressive disease]

    5. Safety [every cycle]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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 91010
    2 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 60612
    3 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 United States 10021
    4 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 77030

    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 9AM - 5 PM Eastern Time (UTC/GMT- 5 hours,EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00452257
    Other Study ID Numbers:
    • 10724
    • H6Q-MC-S022
    First Posted:
    Mar 27, 2007
    Last Update Posted:
    Mar 19, 2009
    Last Verified:
    Mar 1, 2009
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid

    Study Results

    No Results Posted as of Mar 19, 2009