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A Study of Enzastaurin in Patients With Leukemia
This study has been completed.
First Received: March 23, 2007   Last Updated: March 18, 2009   History of Changes
Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00452257
  Purpose

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 Intervention Phase
Leukemia, Lymphocytic
Drug: enzastaurin
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1b Pharmacokinetic-Pharmacodynamic-Pharmacogenomic Study of Enzastaurin in Patients With B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To characterize the inhibitory effects of enzastaurin on the pGSK3 beta level in B-CLL cells. [ Time Frame: baseline, cycle 1, end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of activity of PKC beta in B-CLL cells [ Time Frame: baseline, end of study ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Time to progressive disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: May 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, up to 3 years or until progressive disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452257

Locations
United States, California
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
United States, Illinois
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
United States, 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.
New York, New York, United States, 10021
United States, Texas
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
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly ( Chief Medical Officer )
Study ID Numbers: 10724, H6Q-MC-S022
Study First Received: March 23, 2007
Last Updated: March 18, 2009
ClinicalTrials.gov Identifier: NCT00452257     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Lymphatic Diseases
Leukemia
Chronic Lymphocytic Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, Chronic
Lymphoproliferative Disorders
Leukemia, B-Cell

Additional relevant MeSH terms:
Lymphatic Diseases
Leukemia
Neoplasms
Leukemia, Lymphoid
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoproliferative Disorders
Leukemia, B-Cell

ClinicalTrials.gov processed this record on September 10, 2009