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

NCT00585416 | Terminated Phase 2 DMC

• 3 other identifiers: HSC2006-0099CO0680147-02-001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Hormone Refractory; Metastatic

Outcome Measures

Primary Outcomes (1)

• Efficacy

  8 weeks

Secondary Outcomes (1)

• Safety

  Throughout and for 28 days post drug

Study Arms (1)

1

EXPERIMENTAL

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

Drug: CGC-11047

Interventions

CGC-11047 DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Progen Pharmaceuticals: collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

CGC 11047

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 3, 2008
• Study Start: June 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: March 1, 2009
• Last Updated: October 2, 2015

Record last verified: 2009-04

Locations

US (1)