التفاصيل البيبلوغرافية
| العنوان: |
A phase 2 study of ontuxizumab, a monoclonal antibody targeting endosialin, in metastatic melanoma. |
| المؤلفون: |
D’Angelo, Sandra P., Hamid, Omid A., Tarhini, Ahmad, Schadendorf, Dirk, Chmielowski, Bartosz, Collichio, Frances A., Pavlick, Anna C., Lewis, Karl D., Weil, Susan C., Heyburn, John, Schweizer, Charles, O’Shannessy, Daniel J., Carvajal, Richard D. |
| المصدر: |
Investigational New Drugs; Feb2018, Vol. 36 Issue 1, p103-113, 11p |
| مصطلحات موضوعية: |
THERAPEUTIC use of monoclonal antibodies, BIOMARKERS, CONFIDENCE intervals, CLINICAL drug trials, FATIGUE (Physiology), HEADACHE, MELANOMA, METASTASIS, MONOCLONAL antibodies, NAUSEA, NEOVASCULARIZATION, DISEASE progression, DESCRIPTIVE statistics |
| مستخلص: |
Objectives Ontuxizumab (MORAB-004) is a first-in-class monoclonal antibody that interferes with endosialin function, which is important in tumor stromal cell function, angiogenesis, and tumor growth. This Phase 2 study evaluated the 24-week progression-free survival (PFS) value, pharmacokinetics, and tolerability of 2 doses of ontuxizumab in patients with metastatic melanoma. Patients and methods Patients with metastatic melanoma and disease progression after receiving at least 1 prior systemic treatment were randomized to receive ontuxizumab (2 or 4 mg/kg) weekly, without dose change, until disease progression. Results Seventy-six patients received at least 1 dose of ontuxizumab (40 received 2 mg/kg, 36 received 4 mg/kg). The primary endpoint, 24-week PFS value, was 11.4% (95% Confidence Interval [CI]: 5.3%–19.9%) for all patients (13.5% for 2 mg/kg and 8.9% for 4 mg/kg). The median PFS for all patients was 8.3 weeks (95% CI: 8.1–12.3 weeks). One patient receiving 4 mg/kg had a partial response, as measured by Response Evaluation Criteria in Solid Tumors v1.1. Twenty-seven of 66 response evaluable patients (40.9%) had stable disease. The median overall survival was 31.0 weeks (95% CI: 28.3–44.0 weeks). The most common adverse events overall were headache (55.3%), fatigue (48.7%), chills (42.1%), and nausea (36.8%), mostly grade 1 or 2. Conclusions Ontuxizumab at both doses was well tolerated. The 24-week PFS value was 11.4% among all ontuxizumab-treated patients. The overall response rate was 3.1% at the 4 mg/kg dose, with clinical benefit achieved in 42.4% of response evaluable patients. Efficacy of single-agent ontuxizumab at these doses in melanoma was low. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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