Clinical trial · Interventional
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)
NCT00585416CI-TRIAL-00019317terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Further evaluation of phase I dosing
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CGC-11047 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- CGC-11047 IV weekly for 3 weeks followed by one rest week (4weeks=1cycle)
- interventionNames
- Drug: CGC-11047
Primary outcomes (1)
- measure
- Efficacy
- timeFrame
- 8 weeks
Secondary outcomes (1)
- measure
- Safety
- timeFrame
- Throughout and for 28 days post drug
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.