Clinical trial NCT00309140: An Open Label Study of Oral Enzastaurin in Participants With Cancer
Official title: An Open-Label Study of Oral Enzastaurin HCl in Patients With Advanced or Metastatic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-03-31
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will collect further basic safety data on participants with cancer treated with enzastaurin. This study is not open to the public.

The purpose of the this study is to extend the clinical experience of participants who complete enzastaurin therapy per clinical pharmacology and biopharmaceutics studies conducted by Eli Lilly and Company and who may benefit from continued enzastaurin therapy.


Eligibility criteria: Inclusion Criteria:

* You must have previously participated in and finished Study H6Q-LC-JCAV (JCAV), Study H6Q-LC-JCAY (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 participants 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, participants 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. Participants 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.

Primary outcomes:
measure: Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
timeFrame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Secondary outcomes:
measure: Time to Disease Progression (Time to Documented Tumor Activity)
timeFrame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
measure: Percentage of Participants With Best Overall Response (Documented Antitumor Activity)
timeFrame: Baseline through study completion (up to 26 months and 30-day safety follow-up)
Other outcomes:
Locations:
city: Sun City
country: United States
facility: 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.
state: Arizona
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: