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AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

A Phase II Trial of AZD0530 in Hormone Refractory Prostate Cancer (HRPC)

NCT00513071•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed Description

PRIMARY OBJECTIVES: I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC). II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530. III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population. OUTLINE: This is a multicenter study. Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically or cytologically confirmed prostate cancer with a Gleason score available or interpretable and meeting 1 of the following criteria:
•* No prior chemotherapy and relatively minimal cancer spread
•* Only one prior taxane-based chemotherapy for aggressive and/or symptomatic disease
•Must have prostate cancer considered to be hormone refractory or androgen independent by one or more of the following criteria (despite androgen deprivation and anti-androgen withdrawal when applicable):
•* Progression of unidimensionally measurable disease assessed within 28 days prior to initial administration of drug
•* Progression of evaluable but not measurable disease assessed within 28 days prior to initial administration of drug for PSA evaluation and within 42 days for imaging studies (e.g., bone scans)
•Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and non-target lesions (e.g., PSA level) assessed within 28 days prior to initial administration of drug
•* Measurable disease is not required but is allowed
•Must be surgically or medically castrated
•* If the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide or goserelin), then the patient must be willing to continue the use of LHRH agonists
+13 more criteria

Exclusion Criteria

•Known brain metastases
•History of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
•Patients with any of the following conditions that impair the ability to swallow AZD0530 tablets
•* Gastrointestinal tract disease resulting in an inability to take oral medication or requiring IV alimentation
•* Prior surgical procedures affecting absorption
•* Active peptic ulcer disease
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
•Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
•Use of specifically prohibited CYP3A4-active agents or substances
•* Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
+3 more criteria

Locations (1)

City of Hope

Duarte, California, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

October 1, 2008

Completion Date

October 1, 2008

Last Updated

April 19, 2018

Enrollment

ACTUAL participants

Conditions

Hormone-resistant Prostate CancerRecurrent Prostate Cancer

Interventions

saracatinib

DRUG

laboratory biomarker analysis

OTHER

Gene Expression in Patients With Metastatic Prostate Cancer Receiving CYP-17 Inhibition Therapy

NCT01953640

Hormone-Resistant Prostate CancerMetastatic Prostate Carcinoma+2 more

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ACTIVE_NOT_RECRUITINGPHASE2

Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide

NCT02312557

Castration-Resistant Prostate CarcinomaHormone-Resistant Prostate Cancer+3 more

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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: April 19, 2018Data 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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AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Inclusion Criteria

Exclusion Criteria

Gene Expression in Patients With Metastatic Prostate Cancer Receiving CYP-17 Inhibition Therapy

Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide

Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer After Undergoing Surgery

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Treatment of Locally Recurrent Prostate Cancer

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