NCT00452257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2007

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

1.3 years

First QC Date

March 23, 2007

Last Update Submit

March 18, 2009

Conditions

Leukemia, Lymphocytic

Outcome Measures

Primary Outcomes (1)

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

    baseline, cycle 1, end of study

Secondary Outcomes (5)

  • Evaluation of activity of PKC beta in B-CLL cells

    baseline, end of study

  • Response rate

    baseline to measured progressive disease

  • Duration of response

    time of response to progressive disease

  • Time to progressive disease

    baseline to measured progressive disease

  • Safety

    every cycle

Study Arms (1)

A

EXPERIMENTAL
Drug: enzastaurin

Interventions

enzastaurinDRUG

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

Also known as: LY317615
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are eligible to be included in the study only if they meet all of the following criteria:
  • Patients with B-cell CLL as diagnosed by expression of CD19, CD5, and CD23 by flow cytometry.
  • Rai Stage III or IV disease or earlier stage disease with indications for therapy per NCI Working Group criteria (Cheson et al. 1996)
  • Absolute lymphocyte count \> or = to 5,000/microliter, with a lymphocyte WBC differential of \> or = to 70%.
  • Platelet count \>20,000/microliter.
  • 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.

You may not qualify if:

  • Patients will be excluded from the study if they meet any of the following criteria:
  • Are unable to swallow tablets.
  • Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin.
  • Are pregnant or breastfeeding.
  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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.

Duarte, California, 91010, United States

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.

Chicago, Illinois, 60612, United States

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.

New York, New York, 10021, United States

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.

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphoid

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2007

First Posted

March 27, 2007

Study Start

May 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 19, 2009

Record last verified: 2009-03

Locations

US(4)