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An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies

Phase 2
18 Years
Not Enrolling
Neoplasms, Cancer

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Trial Information

An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies

Inclusion Criteria:

- You must have previously participated in and finished study JCAV, JCAY or other
enzastaurin clinical pharmacology and biopharmaceutics studies. If you have had any
other cancer treatment (chemotherapy, radiation, anti-cancer hormone therapy), you
must have completed it at least 4 weeks ago before you can enroll in this study.

- You must have a cancer for which no other therapy exists that can prolong your life.
This may include patients with treated, stable brain cancer.

- You must have lesions (areas of cancer in your body) that your doctor can either
measure or detect.

- You either must not be able to become pregnant, (because you've had surgery ["tubes
tied" or hysterectomy], you've gone through menopause, or you've had previous
radiation for cancer that made you sterile) or your potential to become pregnant must
be reduced by the use of an approved birth control method (including intrauterine or
barrier devices) during and for 3 to 6 months following the study.

- You can be either male or female, and must be at least 18 years old.

Exclusion Criteria:

- You must not have received treatment within the last 30 days with a drug other than
enzastaurin that is still experimental (this means it has not received approval to be
prescribed, except in a clinical trial).

- You must not be pregnant or breastfeeding.

- You must not have central nervous system (CNS) tumors (tumors in your brain and
spinal cord). (However, patients who have stable CNS tumors and are taking steroid
medication may be included.)

- You must not have another serious disorder, including active infections that will
interfere with your participation in the study.

- You must not have a second cancer in addition to your primary cancer. Patients with
adequately treated skin cancer or who have had another cancer in the past, but have
been cancer free for more than 2 years, are eligible.

Type of Study:


Study Design:

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

Outcome Measure:

This study will collect basic safety data on patients cancer treated with enzastaurin.

Outcome Time Frame:

every cycle

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

July 2009

Related Keywords:

  • Neoplasms
  • Cancer
  • Neoplasms



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. Phoenix, Arizona  85012