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



Status:Terminated
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2006
End Date:March 2009

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A Phase II Study of CGC-11047 in Patients With Metastatic Hormone Refractory Prostate Cancer (47-02-001)

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
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Madison, Wisconsin 53792
(608) 263-6400
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