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Phase 2 Trial of Enzastaurin in Prostate Cancer in Participants Who Have Had Hormonal and Chemotherapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy

NCT00428714•Eli Lilly and Company

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•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).

Exclusion Criteria

•Your organs must be functioning properly.
•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.

Locations (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, United States

Stanford, California, United States

New Haven, Connecticut, United States

Ann Arbor, Michigan, United States

Las Vegas, Nevada, United States

Buffalo, New York, United States

New York, New York, United States

Cleveland, Ohio, United States

Lancaster, Pennsylvania, United States

Memphis, Tennessee, United States

Key Dates

Start Date

January 1, 2007

Primary Completion Date

June 1, 2009

Completion Date

January 1, 2011

Last Updated

November 25, 2020

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

enzastaurin

DRUG

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC