NCT00401765

A Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Combined With Docetaxel in Subjects With Metastatic Hormone-Refractory Prostate Cancer

Completed Phase 1 Last updated 23 May 2014

What this trial tests

Phase 1 trial testing CNTO 328 in Prostatic Neoplasms in 40 participants. Completed in 1 November 2009.

Timeline

1 September 2005

Primary endpoint
1 November 2009

1 November 2009

Quick facts

Lead sponsor	Centocor, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 September 2005
Primary completion	1 November 2009
Estimated completion	1 November 2009
Sites	5 locations across United States

Drugs / interventions tested

• CNTO 328 — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →

Conditions studied

• Prostatic Neoplasms — all drugs for Prostatic Neoplasms →

Sponsor

Centocor, Inc. — full company profile →

Who can join

18 and older, male only, with Prostatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Patients With Adverse Events as a Measure of Safety and Tolerability
  Time frame: Up to 1 year after the last study medication administration
• Plasma Concentration of Docetaxel
  Time frame: predose, post dose (up to 6 hours), and Week 4 (end of treatment visit)
• Serum Concentration of Docetaxel in Combination With CNTO 328
  Time frame: predose, post dose (up to 6 hours), and up to Week 4 (end of treatment visit)

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting the IL-6/JAK/STAT3 signalling axis in cancer.
   Johnson DE, O'Keefe RA, Grandis JR. · · 2018 · cited 2398× · PMID 29405201 · DOI 10.1038/nrclinonc.2018.8
2. Inflammation and tumor progression: signaling pathways and targeted intervention.
   Zhao H, Wu L, Yan G, Chen Y, et al · · 2021 · cited 1932× · PMID 34248142 · DOI 10.1038/s41392-021-00658-5
3. Targeting cytokine and chemokine signaling pathways for cancer therapy.
   Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
4. Unraveling the complexity of STAT3 in cancer: molecular understanding and drug discovery.
   Hu Y, Dong Z, Liu K. · · 2024 · cited 159× · PMID 38245798 · DOI 10.1186/s13046-024-02949-5
5. Multi-stage mechanisms of tumor metastasis and therapeutic strategies.
   Liu Z, Chen J, Ren Y, Liu S, et al · · 2024 · cited 92× · PMID 39389953 · DOI 10.1038/s41392-024-01955-5
6. Dynamics of Cellular Plasticity in Prostate Cancer Progression.
   Tiwari R, Manzar N, Ateeq B. · · 2020 · cited 30× · PMID 32754615 · DOI 10.3389/fmolb.2020.00130
7. Impact of STAT Proteins in Tumor Progress and Therapy Resistance in Advanced and Metastasized Prostate Cancer.
   Ebersbach C, Beier AK, Thomas C, Erb HHH. · · 2021 · cited 27× · PMID 34638338 · DOI 10.3390/cancers13194854
8. The effect of clinical trial participation versus non-participation on overall survival in men receiving first-line docetaxel-containing chemotherapy for metastatic castration-resistant prostate cancer.
   Goyal J, Nuhn P, Huang P, Tyagi P, et al · · 2012 · cited 24× · PMID 22702837 · DOI 10.1111/j.1464-410x.2012.11286.x