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COMPLETEDPHASE2

EPO906 Therapy in Patients With Prostate Cancer

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Androgen-independent Prostate Cancer

NCT00035113•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause prostate cancer.

Eligibility

Age

18 - 85 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•The following patients may be eligible for this study:
•Patients with any histologically proven prostate cancer with measurable metastatic disease or PSA progression \> 20ng/ml after initial hormonal therapy will be eligible
•Patients must be maintained on androgen ablation therapy with a LHRH agonist or have undergone orchiectomy
•Patients in whom bicalutamide or flutamide has been recently withdrawn must demonstrate progression of disease and be at least 6 weeks and 4 weeks respectively, beyond the discontinuation of such agents
•Patients taking PC-SPES must discontinue therapy for a minimum of 4 weeks
•For patients with disease progression defined solely by PSA increase: two consecutive rises in PSA measurement, over a 4-week period (each separated from the previous by 2 weeks) - the last measurement must be at least 50% greater than the nadir PSA achieved after the last therapeutic maneuver
•For patients who discontinued bicalutamide therapy prior to study entry, a third rising PSA measurement is required 2 weeks from the second PSA measurement (i.e. over a 6 week period)
•Must have a life expectancy of greater than three (3) months
•Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be up to 2.5 X institutional upper limit of normal if alkaline phosphatase is less than the upper limit of normal, or alkaline phosphatase may be up to 4 X upper limit of normal if transaminases are less than or equal to the upper limit of normal
•For patients with disease progression defined by measurable disease: changes in measurable size of lymph nodes or parenchymal masses on physical or radiologic examination (bone scan findings are not adequate to assess measurable disease).

Exclusion Criteria

•Patients with symptomatic CNS metastases or leptomeningeal involvement
•Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
•Patients with severe cardiac insufficiency
•Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
•Patients who received palliative radiotherapy to tumors located centrally less than 4 weeks (28 days) prior to planned enrollment date (palliative radiotherapy to isolated peripheral bone metastases is allowed)
•Patients experiencing hormone withdrawal syndrome, or are 28 days post-withdrawal of anti-androgen therapy (42 days for bicalutamide)
•Patients who have had more than one prior chemotherapy regimen for hormone-resistant metastatic disease
•Patients with disease measurable only by bone scan
•Patients who have received corticosteroids within the past 28 days (may be waived with approval from Novartis)
•History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer
+4 more criteria

Locations (5)

Pacific Shores Medical Group

Long Beach, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of Maryland - Greenbaum Cancer Center

Baltimore, Maryland, United States

Cancer Institute of New Jersey (CINJ)

New Brunswick, New Jersey, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Key Dates

Start Date

January 1, 2002

Primary Completion Date

January 1, 2004

Completion Date

January 1, 2004

Last Updated

February 9, 2017

Enrollment

ACTUAL participants

Conditions

Prostatic Neoplasms

Interventions

epothilone b

DRUG

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

NCT07225946

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITINGPHASE1/PHASE2

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

NCT04868604

Prostatic Neoplasms, Castration-Resistant

View study

RECRUITING

Prostate Active Surveillance Study

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: February 9, 2017Data 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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EPO906 Therapy in Patients With Prostate Cancer

Inclusion Criteria

Exclusion Criteria

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)

Prostate Active Surveillance Study

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas

Clinical Application of the J-PET Scanner Prototype