NCT00466440

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Jun 2007

Geographic Reach
3 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

November 6, 2020

Completed
Last Updated

November 6, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

April 25, 2007

Results QC Date

October 9, 2020

Last Update Submit

October 9, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Part 2: Percentage of Participants With Objective Tumor Response (Response Rate)

    Response using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD)=20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=small changes that do not meet above criteria. Objective response rate (%)=number of objective responders divided by the number of participants qualified for efficacy analysis \*100, where objective responders are those participants who have met criteria either for CR or PR.

    Baseline up to 3 years

Secondary Outcomes (12)

  • Percentage of Participants Exhibiting a Decline in Prostate-Specific Androgen (PSA) From Baseline ≥30% Within First 3 Months of Treatment

    Baseline up to 3 months

  • Prostate-Specific Androgen (PSA) Velocity at 2 Months

    Baseline up to 2 months

  • Prostate-Specific Androgen (PSA) Velocity at 3 Months

    Baseline up to 3 months

  • Part 2: Progression Free Survival (PFS)

    Baseline to measured PD (up to 487 days)

  • Part 2: Overall Survival (OS)

    Baseline to death (up to 642 days)

  • +7 more secondary outcomes

Study Arms (3)

docetaxel + prednisone + enzastaurin

EXPERIMENTAL

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).

Drug: enzastaurinDrug: docetaxelDrug: prednisone

docetaxel + prednisone + placebo

PLACEBO COMPARATOR

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.

Drug: placebo

docetaxel + prednisone + enzastaurin (modified Regimen A)

EXPERIMENTAL

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).

Drug: enzastaurinDrug: docetaxelDrug: prednisone

Interventions

enzastaurinDRUG

1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years

Also known as: LY317615
docetaxel + prednisone + enzastaurindocetaxel + prednisone + enzastaurin (modified Regimen A)
placeboDRUG

Loading dose, then po QD until unblinding

docetaxel + prednisone + placebo
docetaxelDRUG

75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles

docetaxel + prednisone + enzastaurindocetaxel + prednisone + enzastaurin (modified Regimen A)
prednisoneDRUG

5 mg po BID, six 21-day cycles

docetaxel + prednisone + enzastaurindocetaxel + prednisone + enzastaurin (modified Regimen A)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

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.

Fullerton, California, 92835, United States

Location

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.

Los Angeles, California, 90093, United States

Location

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Northridge, California, 91328, United States

Location

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Redondo Beach, California, 90277, United States

Location

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Santa Barbara, California, 93105, United States

Location

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Santa Maria, California, 93454, United States

Location

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Miami, Florida, 33179, United States

Location

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Chicago, Illinois, 60637, United States

Location

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.

Harvey, Illinois, 60426, United States

Location

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.

Minneapolis, Minnesota, 55404, United States

Location

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.

Columbia, Missouri, 65201, United States

Location

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.

Kansas City, Missouri, 64128, United States

Location

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.

Billings, Montana, 59101, United States

Location

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.

Henderson, Nevada, 89169, United States

Location

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.

Las Cruces, New Mexico, 88011, United States

Location

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.

Raleigh, North Carolina, 27607, United States

Location

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.

Cleveland, Ohio, 44195, United States

Location

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.

Memphis, Tennessee, 38138, United States

Location

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.

Dallas, Texas, 75246, United States

Location

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.

The Woodlands, Texas, 77380, United States

Location

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.

Newport News, Virginia, 23606, United States

Location

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.

Vancouver, Washington, 98684, United States

Location

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.

Erlangen, 91054, Germany

Location

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.

Hamburg, 22399, Germany

Location

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.

Mannheim, 68163, Germany

Location

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.

Como, 22100, Italy

Location

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.

Orbassano, 10043, Italy

Location

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.

San Sisto, 06156, Italy

Location

Related Publications (1)

  • Dreicer R, Garcia J, Rini B, Vogelzang N, Srinivas S, Somer B, Shi P, Kania M, Raghavan D. A randomized, double-blind, placebo-controlled, Phase II study with and without enzastaurin in combination with docetaxel-based chemotherapy in patients with castration-resistant metastatic prostate cancer. Invest New Drugs. 2013 Aug;31(4):1044-50. doi: 10.1007/s10637-013-9940-0. Epub 2013 Feb 24.

    PMID: 23435622DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzastaurinDocetaxelPrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2007

First Posted

April 27, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2009

Study Completion

June 1, 2010

Last Updated

November 6, 2020

Results First Posted

November 6, 2020

Record last verified: 2020-10

Locations

US(22)IT(3)DE(3)