Phase 2
Completed N=123
A Study of Olaratumab (IMC-3G3) in Prostate Cancer
Source: ClinicalTrials.gov NCT01204710 ↗Enrolled (actual)
123
Serious AEs
37.9%
Results posted
Nov 2018
Primary outcomePrimary: Progression-Free Survival (PFS) — 2.3; 2.4 months — p=0.2201
Summary
This is a study evaluating the safety and efficacy of the monoclonal antibody olaratumab plus mitoxantrone plus prednisone compared to mitoxantrone plus prednisone in metastatic castration-refractory prostate cancer following disease progression or intolerance on docetaxel-based chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
2.3; 2.4 | 0.2201 |
| SECONDARY Overall Survival (OS) |
14.2; 12.8 | 0.7291 |
| SECONDARY Percentage of Participants Who Achieved a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] |
10.0; 3.1 | 0.3465 |
| SECONDARY Percentage of Participants With a ≥50% Decrease in Prostate Specific Androgen (PSA) From Pretreatment to Any Time |
22.6; 18.6 | 0.6571 |
| SECONDARY Percentage of Participants With a ≥30% Decrease in PSA From Pretreatment to Week 12 |
22.6; 16.9 | 0.4986 |
| SECONDARY Summary Listing of Participants Reporting Treatment-Emergent Adverse Events (TEAE) |
26; 21; 6; 52; 51; 15 | — |
| SECONDARY PFS Based on Baseline Circulating Tumor Cells (CTC) Counts |
2.32; 2.23; 2.38; 4.91 | — |
| SECONDARY OS Based on Baseline CTC Counts |
12.85; 8.10; 16.49; 23.00 | — |
| SECONDARY Number of Participants With Negative Platelet-Derived Growth Factor Receptor Alpha (PDGFRα) Protein Expression by Immunohistochemistry (IHC) |
14; 9 | — |
| SECONDARY Percentage of Participants With Anti-Olaratumab Antibody Assessment (Immunogenicity) |
3.8; 0 | — |
| SECONDARY Maximum Concentration (Cmax) of Olaratumab Cycles 1, 2 and 3 |
— | — |
Eligibility Criteria
Inclusion Criteria
- histologically-confirmed adenocarcinoma of the prostate
- radiographic evidence of metastatic prostate cancer (Stage M1 or D2)
- has prostate cancer unresponsive or refractory to medical or surgical castration with a serum testosterone level of 5 mg prednisone PO BID or equivalent
- received prior strontium-89, rhenium-186, rhenium-188, or samarium-153 radionucleotide therapy and has either ongoing evidence of bone marrow dysfunction or poorly controlled bone pain
- has any ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, psychiatric illness, active bleeding or pathological condition that carries a high risk of bleeding, or any other serious uncontrolled medical disorders
- known or suspected brain or leptomeningeal metastases
- known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
Data sourced from ClinicalTrials.gov (NCT01204710). 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.