Clinical trial NCT00192114: Enzastaurin for Patients With Metastatic Colorectal Cancer
Official title: A Phase 2 Study of Oral Enzastaurin HCl in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonic Neoplasms
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Enzastaurin given daily to participants with colorectal cancer who have Stage 4 disease and have not received prior chemotherapy for advanced colorectal cancer


Eligibility criteria: Inclusion Criteria:

* diagnosed with colorectal cancer that is advanced or metastatic (has spread to other parts of the body); able to visit the doctor's office every 28 days for at least 6 months; able to swallow tablets

Exclusion Criteria:

* women cannot be pregnant or breastfeeding; no history of significant heart disease or any other significant medical problems as determined by the participant's physician

Primary outcomes:
measure: Percentage of Participants With Progression Free Survival (PFS) at 6 Months
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
timeFrame: Baseline to measured progressive disease (PD) up to 24 months
measure: Overall Survival (OS)
timeFrame: Baseline to date of death from any cause up to 24 months
measure: Progression Free Survival (PFS)
timeFrame: Baseline to measured PD up to 9 months
measure: Duration of Stable Disease (SD)
timeFrame: Time from SD to measured PD up to 9 months
measure: Time to Treatment Response
timeFrame: Baseline to date of confirmed response up to 24 months
measure: Duration of Complete Response (CR) or Partial Response (PR) (Duration of Response)
timeFrame: Time from response to PD
measure: Number of Participants With Adverse Events (AEs) or Who Died
timeFrame: Baseline to study completion up to 24 months and 30-day post-study discontinuation
measure: Change From Baseline in QTc Interval
timeFrame: Baseline, Cycle 1 Day 1 and Cycle 2 Day 1 of 28-day cycles
measure: Pharmacokinetics-Minimum Observed Concentration (Cmin) of Total Analytes
timeFrame: Cycle 1 Day 2-predose, Cycle 2 Day 1-predose and Cycle 3 Day 1-predose of 28-day cycles
measure: Change From Baseline in Carcinoembryonic Antigen (CEA) Response at Each Cycle
timeFrame: Baseline and Cycles 1, 2, 3, 4, 5, 6 (28-day cycles)
Other outcomes:
measure: Change From Baseline in Vascular Endothelial Growth Factor (VEGF) to Cycle 2 and Cycle 3
timeFrame: Baseline, Cycle 2 and Cycle 3 (28-day cycles)
Locations:
city: Odense
country: Denmark
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.
city: Vejle
country: Denmark
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.
city: Uppsala
country: Sweden
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.
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: