Clinical trial · Interventional
A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer
A Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Combined With Docetaxel in Subjects With Metastatic Hormone-Refractory Prostate Cancer
NCT00401765CI-TRIAL-00014697completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO 328 has an effect on prostate cancer.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CNTO 328 | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1A (Docetaxel and CNTO 328)
- description
- In cohort 1A, 75 mg/m2 docetaxel will be administered in run-in phase and 75 mg/m2 docetaxel every 3 weeks and 6 mg/kg CNTO 328 every 2 weeks will be administered in the treatment phase.
- interventionNames
- Drug: CNTO 328
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- Cohort 1B (Docetaxel and CNTO 328)
- description
- In cohort 1B, 6 mg/kg CNTO 328 will be administered in run-in phase and 75 mg/m2 docetaxel will be administered every 3 weeks plus 6 mg/kg CNTO 328 will be administered every 2 weeks in the treatment phase.
- interventionNames
- Drug: CNTO 328
- Drug: Docetaxel
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * Radiologically documented metastatic disease * No prior systemic chemotherapy for metastatic hormone refractory prostate cancer * Progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or anti-androgen treatment within 12 months of screening based on 1 of the following: Transaxial imaging tumor progression, Rise in 2 consecutive prostate-specifec antigen (PSA) values obtained at least 7 days apart or Radionucleotide bone scan progression * Karnofsky performance status of greater than or equal to 60 Exclusion Criteria: * Prostate cancer that does not express serum PSA or is less than 5.0 ng/mL at screening * Received any investigational drug/agent within 30 days or 5 half-lives, whichever is longer * Prior malignancy (other than prostate cancer) except adequately treated basal cell or squamous cell carcinoma of the skin or other cancer for which the subject has been disease-free for greater than or equal to 3 years * Known central nervous system metastases * Received any over-the-counter or herbal treatment for prostate cancer (eg, PC SPES \[an herbal refined powder\]) within 4 weeks prior to screening.
References
Publications (0)
Data not yet available
No reference posted for this study.