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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00585416

Enrollment

Registered

2008-01-03

Start date

2006-06-30

Completion date

2009-03-31

Last updated

2015-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate Cancer, Hormone Refractory, Metastatic

Brief summary

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.

Interventions

DRUGCGC-11047

CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Efficacy	8 weeks

Secondary

Measure	Time frame
Safety	Throughout and for 28 days post drug

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026