Brief Summary

The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin. Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease. Cohort 2 - participants with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising PSA, clinical, radiographic disease progression following one prior docetaxel-based regimen

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline

Completed

Started Jan 2007

Geographic Reach

1 country

11 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

4 years study duration

Study Start

First participant enrolled

January 1, 2007

Completed

25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed

9.9 years until next milestone

Results Posted

Study results publicly available

November 25, 2020

Completed

Last Updated

November 25, 2020

Status Verified

November 1, 2020

Enrollment Period

2.4 years

First QC Date

January 26, 2007

Results QC Date

October 9, 2020

Last Update Submit

November 4, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

Cohort 1 - Number of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Objective responders were defined as participants (pts) in Cohort 1 who met prostate-specific antigen (PSA) response criteria. PSA Complete response (CR) was defined as a decrease in PSA to an undetectable level (\<0.2 ng/mL) confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease. PSA Partial Response (PR) was defined as a decrease in PSA of \>=50% at any time during the study. The decline of \>=50% in PSA must be from a baseline value of \>5 ng/mL and must be confirmed by a second value obtained at least 4 weeks apart and without clinical or radiographic evidence of disease.
Baseline to Measured Progressive Disease, Death, Unacceptable Toxicities, or Study Closure Whichever Occurred First (up to 56 weeks)
Cohort 2 - Progression-free Survival (PFS)-Overall
PFS was defined as the time from date of enrollment to first occurrence of (1) tumor progression (defined per Response Evaluation Criteria In Solid Tumors \[RECIST\]) for soft tissue lesions, and/or appearance of \>=2 new lesions on bone scan (confirmed \>=6 weeks later); (2) skeletal event (pathological bone fracture and/or need for palliative radiotherapy); (3) symptomatic progression (worsening of Eastern Cooperative Oncology Group (ECOG) performance status (PS) and/or weight loss \>10% from baseline and/or increase in analgesic consumption and pain); or (4) Death due to any cause. PFS was censored at date of last objective progression-free observation for participants who were still alive and had not progressed. Participants who took any subsequent systemic anticancer therapy prior to progression or death were censored at date of last objective progression-free disease assessment prior to the date of the subsequent systemic anticancer therapy.
baseline to first occurrence of tumor progression, skeletal event, symptomatic progression, or death (up to 31.3 weeks)

Secondary Outcomes (10)

Cohort 1 - Number of Participants With a 3-month PSA Level Decline of Greater Than or Equal to 30%
baseline to 3 months
Cohort 1 - PSA Velocity
baseline, 2 months and 3 months
Cohort 1 - Progression-free Survival (PFS)-Overall
baseline to date of disease progression, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
Cohort 1 - Duration of Response
time of response to progressive disease, death, unacceptable toxicities, or study closure whichever occurred first (up to 56 weeks)
Cohort 2 - 3-month PSA Level Decline of Greater Than or Equal to 30%
baseline to 3 months
+5 more secondary outcomes

Study Arms (2)

Enzastaurin-Cohort 1

EXPERIMENTAL

Chemo-naive participants who had androgen-independent prostate cancer with rising prostate-specific antigen (PSA) levels but no clinical or radiographic evidence of metastatic disease. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.

Drug: enzastaurin

Enzastaurin-Cohort 2

EXPERIMENTAL

Participants with progressed, metastatic prostate cancer who had received prior treatment with a docetaxel-containing agent. Participants were given 1125 mg loading dose of enzastaurin on Day 1 of Cycle 1 (28-day cycle) only, and thereafter 500 mg enzastaurin once daily.

Drug: enzastaurin

Interventions

enzastaurinDRUG

Administered orally

Also known as: LY317615

Enzastaurin-Cohort 1Enzastaurin-Cohort 2

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

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

You may qualify if:

You are expected to be alive in the 12 weeks.
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 (cohort 1).
Must have evidence of androgen-independent PSA-progressive disease without a history of or current (as judged by the investigator) clinical or radiographic evidence of metastatic disease with castrate levels of testosterone (\<50 ng/dL) maintained by luteinizing hormone-releasing hormone (LHRH) agonist or bilateral orchiectomy following standard anti-androgen withdrawal. NOTE: PSA progression is defined as have rising PSA values of \<=5 ng/mL (at least 3 measurements 1 week apart) with castrate levels of testosterone \<50 ng/dL following appropriate antiandrogen withdrawal, without evidence of metastases. (cohort 1)
No prior systemic chemotherapy for prostate cancer. No prior chemotherapy for any other indication within 2 years of study entry. NOTE: Participants previously treated with chemotherapy in the adjuvant/neoadjuvant setting were not be eligible. (cohort 1)
You have had one prior docetaxel-based chemotherapy regimen (cohort 2).
You have evidence of metastatic prostate cancer with bone or soft tissue disease (cohort 2).
Must have evidence of docetaxel-resistant, androgen-independent metastatic prostate cancer with bone or soft tissue disease (PSA only participants are not eligible) defined as either: clinical, PSA or radiographic disease progression while receiving docetaxel-based therapy or PSA and/or radiographic progression at any time after completion of a docetaxel-containing regimen with PSA progression defined as a 25% increase in PSA from the post docetaxel value or interval progression in known metastatic sites of disease or development of new sites of disease on bone scan or computed tomography (CT) imaging. Note: Participants who discontinued a docetaxel-containing regimen due to toxicity or any other reasons not related to disease progression while on treatment, and were not able to complete at least 2 cycles, were not be eligible. (cohort 2)
Your organs must be functioning properly.

You may not qualify if:

You are unable to swallow pills.
You have another 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

Eli Lilly and Companylead

Study Sites (11)

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, 90025, United States

Location

Stanford, California, 94305, United States

Location

New Haven, Connecticut, 06520, United States

Location

Ann Arbor, Michigan, 48109, United States

Location

Las Vegas, Nevada, 89135, United States

Location

Buffalo, New York, 14263, United States

Location

New York, New York, 10032, United States

Location

Cleveland, Ohio, 44195, United States

Location

Lancaster, Pennsylvania, 17605, United States

Location

Memphis, Tennessee, 38120, United States

Location

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

Dreicer R, Garcia J, Hussain M, Rini B, Vogelzang N, Srinivas S, Somer B, Zhao YD, Kania M, Raghavan D. Oral enzastaurin in prostate cancer: a two-cohort phase II trial in patients with PSA progression in the non-metastatic castrate state and following docetaxel-based chemotherapy for castrate metastatic disease. Invest New Drugs. 2011 Dec;29(6):1441-8. doi: 10.1007/s10637-010-9428-0. Epub 2010 Apr 6.
PMID: 20369375DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzastaurin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

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: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 30, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

January 1, 2011

Last Updated

November 25, 2020

Results First Posted

November 25, 2020

Record last verified: 2020-11

Locations

US(11)

Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (2)

Enzastaurin-Cohort 1

Enzastaurin-Cohort 2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (10)

Study Arms (2)

Enzastaurin-Cohort 1

Enzastaurin-Cohort 2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations