A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients

Lilly

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: docetaxel; Drug: placebo; Drug: enzastaurin; Drug: prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00466440

H6Q-MC-S032 (Other Identifier)

11311 (Registry Identifier)

Details and patient eligibility

About

The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.

Enrollment: 108 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• You are at least 18 years old.
• You live close enough to the doctor's office to attend all of your required visits.
• You have not been treated with chemotherapy for your prostate cancer.
• Your organs must be functioning properly.

Exclusion criteria

• You are unable to swallow pills.
• You have another serious illness besides your prostate cancer.
• You have taken another experimental drug within the last 30 days.
• You have a serious heart condition.
• You are receiving another anti-cancer therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 3 patient groups, including a placebo group

docetaxel + prednisone + enzastaurin

Experimental group

Description:

Regimen A: docetaxel 75 milligrams per square meter (mg/m\^2), intravenous (IV) is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 milligrams (mg) oral (po), twice daily (BID) every day. In Cycle 1, enzastaurin is given as a loading dose of 1125 mg on the day prior to docetaxel and prednisone therapy, followed by enzastaurin 500 mg po, daily (QD) for the remaining Period 2 (chemotherapy) and Period 3 (maintenance).

Treatment:

Drug: prednisone

Drug: enzastaurin

Drug: docetaxel

docetaxel + prednisone + placebo

Placebo Comparator group

Description:

Regimen B: docetaxel 75 mg/m\^2, IV is administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, placebo is given as a loading dose on the day prior to docetaxel and prednisone therapy, followed by po, QD placebo for the remaining Period 2 (chemotherapy) and Period 3 (maintenance), until unblinding.

Treatment:

Drug: placebo

docetaxel + prednisone + enzastaurin (modified Regimen A)

Experimental group

Description:

Modified Regimen A, including pharmacokinetic (PK) characterization: Participants were treated with a modified investigational regimen with no dose escalation: docetaxel 75 mg/m2, IV was administered on Day 1 every 3 weeks for 6 cycles (maximum up to 10 cycles) and prednisone 5 mg po, BID every day. In Cycle 1, enzastaurin was given as a loading dose of 1125 mg starting on Day 4, followed by enzastaurin 500 mg po, QD for the remaining Period 2 (chemotherapy) and Period 3 (maintenance).

Treatment:

Drug: prednisone

Drug: enzastaurin

Drug: docetaxel