Conditions

Outcome Measures

Progression Free Survival (PFS)
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. Progressive disease was determined using a modified version of Response Evaluation Criteria in Solid Tumor (RECIST) Assessment and was defined as at least a 20% increase in sum of longest diameter of target lesions. Time to disease progression was censored at the date of death if death was due to other cause.
Randomization to measured progressive disease or death up to 17.2 months

Overall Survival (OS)
Randomization up to 22.8 months
Number of Participants With Adverse Events (AEs)
Randomization up to 17.2 months
Overall Survival (OS) From Start of First Line Therapy
Start of first line therapy (approximately 3 months prior to randomization) to date of death from any cause up to 27 months post randomization
PFS From Start of First Line Therapy
Start of first line therapy to measured progressive disease or death up to 24 months

EXPERIMENTAL

5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin

Drug: EnzastaurinDrug: Leucovorin (LV)Drug: 5-fluorouracil (5-FU)Drug: Bevacizumab (Bev)

PLACEBO COMPARATOR

5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo

Drug: PlaceboDrug: Leucovorin (LV)Drug: 5-fluorouracil (5-FU)Drug: Bevacizumab (Bev)

1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease

Also known as: LY317615

Enzastaurin + 5-FU/LV + Bev

oral, daily (up to 1 yr or until progressive disease)

Placebo + 5-FU/LV + Bev

400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Enzastaurin + 5-FU/LV + BevPlacebo + 5-FU/LV + Bev

400 mg/m\^2 bolus then 2400 mg/m\^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Enzastaurin + 5-FU/LV + BevPlacebo + 5-FU/LV + Bev

5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Enzastaurin + 5-FU/LV + BevPlacebo + 5-FU/LV + Bev

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Histologic diagnosis of locally advanced or metastatic colorectal cancer (CRC) that is not curable. The histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. Patients with neuroendocrine carcinomas will be excluded.
Received 6 cycles (3 months \[12 weeks\]) of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for metastatic CRC. Patients have received at least 5 cycles with bevacizumab. Patients who received 6 cycles of first-line therapy with FOLFOX or FOLFIRI, plus bevacizumab for recurrent CRC that has relapsed at least 12 months after completion of adjuvant therapy will also be included. All standard FOLFOX (FOLFIRI) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed.
No more than 4 weeks may pass between the end of first-line therapy (that is, Day 14 of Cycle 6) and randomization.
Documented evidence of tumor response of complete response (CR), partial response (PR), or stable disease (SD) by computed tomography (CT) scan or magnetic resonance imaging (MRI). Confirmation of response is not required.

Are unable to swallow tablets.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Have known central nervous system metastases.
Are receiving concurrent administration of any other antitumor therapy.
Patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection

Contact the study team to confirm eligibility.