Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this research is to determine the effectiveness of CGC-11047 in subjects with metastatic hormone refractory prostate cancer as measured by changes in PSA.

Key facts

Study ID

NCT00585416

Run by

University of Wisconsin, Madison

People needed

23

Starts

2006-06-01

Expected to finish

2009-03-01

Last updated by the study team

2015-10-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Metastatic hormone refractory prostate cancer.
• Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.
• testosterone <50ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue if they have not undergone orchiectomy.
• Progressive disease after androgen deprivation.

You may not qualify if…

• Patients whose clinical condition would make chemotherapy clearly indicated.
• Patients who have received systemic chemotherapy for the treatment of metastatic disease.
• Peripheral neuropathy > Grade 1
• Prior anti-angiogenic therapy, including thalidomide.
• Patients with inadequate recovery from any prior surgical procedure, or patients having undergone any major surgical procedure or radiation within 4 weeks prior to study entry.
• Patients who have received radiopharmaceuticals (strontium, samarium) within 8 weeks prior to enrollment.
• Patients with known brain metastases or history of brain metastases.
• History of stroke within 6 months of treatment or other significant neurological limitations.
• Patients who have received more than 2 prior investigational treatments.
• Uncontrolled intercurrent illness
• Patients with a history of a myocardial infarction within the prior 6 months or, hospitalizations for decompensated congestive heart failure within the prior 6 months, or history of significant / symptomatic cardiac arrhythmias

Where it is running

• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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