Phase 2
Completed N=46
A Study of the Safety and Efficacy of Single-agent Carlumab (an Anti-Chemokine Ligand 2 [CCL2]) in Participants With Metastatic Castrate-Resistant Prostate Cancer
Source: ClinicalTrials.gov NCT00992186 ↗Enrolled (actual)
46
Serious AEs
43.5%
Results posted
May 2013
Primary outcomePrimary: Percentage of Participants With Composite Response — 0.0; 0.0; 2.4 Percentage of participants
Summary
The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer (cancer of the gland that makes fluid that aids movement of sperm).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite Response |
0.0; 0.0; 2.4 | — |
| SECONDARY Percentage of Participants With Objective Tumor Response |
0.0; 0.0 | — |
| SECONDARY Progression-Free Survival (PFS) |
81.0 | — |
| SECONDARY Overall Survival (OS) |
309.0 | — |
| SECONDARY Percentage of Participants With Prostate Specific Antigen (PSA) Response |
0.0 | — |
| SECONDARY Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response |
0.0 | — |
| SECONDARY Percentage of Participants With Pain Response |
32.3; 38.7 | — |
| SECONDARY Time to Radiologic Response |
— | — |
| SECONDARY Duration of Radiologic Response |
— | — |
| SECONDARY Minimum Observed Serum Concentration (Cmin) |
91.82 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) |
320.27 | — |
| SECONDARY Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d) |
1635.67 | — |
| SECONDARY Half-life (t1/2) |
13.32 | — |
Eligibility Criteria
Inclusion Criteria
- Histological documentation of adenocarcinoma of the prostate
- Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
- Serum prostate specific antigen (PSA) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
- Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
- At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
Exclusion Criteria
- Experience a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement)
- Known or symptomatic Central Nervous System metastases
- Residual toxicities resulting from previous therapy that are Grade 2 or more (except for alopecia)
- Known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
- Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
Data sourced from ClinicalTrials.gov (NCT00992186). 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.