| General information |
| Database: | DB00933 |
| Objective: | Cixutumumab, a human monoclonal antibody (HuMAb), targets the insulinlike growth factor receptor. Ramucirumab is a recombinant HuMAb that binds to vascular endothelial growth factor receptor2. A noncomparative randomisedphase II study evaluated cixutumumab or ramucirumab plus mitoxantrone and prednisone (MP) in metastatic castrationresistant prostate cancer (mCRPC) |
| Authors: | Hussain M, et al |
| Title: | A randomised noncomparativephase II trial of cixutumumab (IMCA12) or ramucirumab (IMC1121B) plus mitoxantrone and prednisone in men with metastatic docetaxelpretreated castrationresistant prostate cancer. |
| Journal: | Eur J Cancer. |
| Year: | 2015 |
| PMID: | 26082390 |
| Trial Design |
| Clinical Trial Id: | NCT00683475 |
| Agent: | Cixutumumab ramucirumab
|
| Target: | NA
|
| Cancer Type: | prostate cancer |
| Cancer Subtype: | advanced castrationresistant prostate cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cixutumumab (IMCA12) or ramucirumab (IMC1121B) + mitoxantrone + prednisone |
| Study Type: | A randomised noncomparativephase II trial |
| Key Patients Feature: | Men with progressive mCRPC during or after docetaxel therapy |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | ramucirumab (IMC1121B) plus mitoxantrone and prednisone versus cixutumumab (IMCA12) plus mitoxantrone and prednisone |
| Treatment Info: | pts received mitoxantrone 12 mg/m(2) on day 1 and prednisone 5mg twice daily and were randomised 1:1 to receive either cixutumumab or ramucirumab 6 mg/kg intravenously weekly in a 21day cycle. |
| Primary End Point: | composite progression free survival (cPFS). |
| Secondary End Point: | safety, response, radiographic progression free survival (PFS) and overall survival (OS). |
| Patients Number: | 132 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 15.2% (cixutumumab) and 31.6% (ramucirumab) |
| Disease Control Rate: | all patients was 65.2% (cixutumumab: 95% CI, 52.4-76.5) and 77.3% (ramucirumab: 95% CI, 65.3-86.7) |
| Median Time to Progression: | 7.5 months for cixutumumab and 10.2 months for ramucirumab |
| Median PFS A vs. C: | 4.1 months (95% confidence interval (CI), 2.25.6) for cixutumumab and 6.7 months (95% CI, 4.58.3) for ramucirumab. |
| Median OS A vs. C: | 10.8 months for cixutumumab and 13.0 months for ramucirumab |
| Adverse Event(agent arm): | NA |
| Conclusions: | Combinations of cixutumumab or ramucirumab plus MP they were feasible and associated with moderate toxicities in docetaxelpretreated men with mCRPC. Of the two regimens, the ramucirumab regimen is worthy of further testing based on the observed cPFS relative to the historical control. |