Phase 2
Completed N=131
An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer
Source: ClinicalTrials.gov NCT00537381 ↗Enrolled (actual)
131
Serious AEs
36.6%
Results posted
May 2013
Primary outcomePrimary: Progression-Free Survival (PFS) — 336.0; 232.0 Days — p=0.014
Summary
The purpose of this study is to assess the effects of intetumumab when given in combination with docetaxel and prednisone to participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body until it kills).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
336.0; 232.0 | 0.014 sig |
| SECONDARY Number of Participants With Best Overall Response (OR) |
1; 0; 9; 8 | 0.795 |
| SECONDARY Number of Participants With Prostate Specific Antigen (PSA) Response |
43; 27 | 0.018 sig |
| SECONDARY Overall Survival |
626.0; 522.0 | 0.163 |
| SECONDARY Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration |
1.45; -30.81; -11.58; -39.78; 2.39; -25.48 | — |
| SECONDARY Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration |
-0.77; -21.37; 1.58; -23.44; 2.55; -21.71 | — |
| SECONDARY Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration |
-10.00; -9.64; -3.10; 11.69; 3.96; 32.11 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed cancer of the prostate
- Evidence of metastatic disease
- Have a life expectancy greater than 12 weeks
- Have at least 4 weeks from previous major surgery to date of first study agent given
- Have progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months prior to the first study agent administration Exclusion Criteria
- Have known Central Nervous System metastases (cancerous tumors that have spread to the brain from somewhere else in the body)
- Had prior systemic non-hormonal therapy for hormone refractory prostate cancer
- Have known Human Immunodeficiency Virus (HIV, a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) seropositivity or known hepatitis B or C infection
- Have planned major surgery during the study
- Have taken any over-the-counter (medicine that can be bought without a prescription) or herbal treatment for prostate cancer within 4 weeks prior to the first study treatment administration
Data sourced from ClinicalTrials.gov (NCT00537381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.