Evaluating E7389 in Patients With Hormone Refractory Prostate Cancer With Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy

Phase 2

Completed

Brief Summary: This is a multi-centre, phase II, open-label, two-stage design, single-arm study in patients with hormone-refractory prostate cancer (HRPC) with advanced (rising PSA) and/or metastatic disease and who have had prior anti-androgen therapy. The study will further explore the efficacy of E7389 by enrollment of patients into two strata: those who have had no prior systemic chemotherapy for their disease (except for mitoxantrone and estramustine), and those who failed no more than one previous chemotherapeutic regimen with tubulin-binding agents such as docetaxel.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
1	E7389	With stratification

Primary Outcome Measures

Name	Time	Method
Objective Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria	12 months	Bubley Criteria: Patients must have progressive disease to enter study. For outcomes, PSA response must show at least 50% decrease. Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir. PSA progressive disease- 25% increase from baseline or increase of 5 ng/mL along with measureable disease Stable disease- decline of less than 50% and not more than 25% increase.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12 months
Progression Free Survival	12 months	From the date study treatment was initiated until the earliest date of the first PSA assessment that determined progressive disease, or the death of death if death occurred without disease progression.
Duration of Prostate Specific Antigen Response Based on Bubley Criteria	12 months.	Duration of response is the time from \>50% decrease from baseline to when there is a 50% decrease in nadir.
Best Objective Tumor Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST) Criteria	12 months	Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

Locations (17): Raleigh Hematology Oncology Associates PL
🇺🇸
Raleigh, North Carolina, United States
Mary Crowley Medical Research Center
🇺🇸
Dallas, Texas, United States
US Oncology
🇺🇸
Dallas, Texas, United States
El Paso Cancer Treatment Center
🇺🇸
El Paso, Texas, United States
Texas Oncology PA
🇺🇸
Tyler, Texas, United States
Deke Slayton Cancer Center
🇺🇸
Webster, Texas, United States
Virginia Oncology Associates
🇺🇸
Norfolk, Virginia, United States
Minnesota Hematology Oncology
🇺🇸
Burnsville, Minnesota, United States
Dr. Robert Jotte
🇺🇸
Denver, Colorado, United States
Melbourne Internal Medicine Associates
🇺🇸
Melbourne, Florida, United States
Ocala Oncology Center PL
🇺🇸
Ocala, Florida, United States
Central Indiana Cancer Centers
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Indianapolis, Indiana, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
New York Oncology Hematology, P.C.
🇺🇸
Albany, New York, United States
Missouri Cancer Associates
🇺🇸
Columbia, Missouri, United States
St. Luke's Roosevelt Hospital Center
🇺🇸
New York, New York, United States
Tyler Cancer Center
🇺🇸
Tyler, Texas, United States