Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2.

@article{Spratlin2010PhaseIP,
  title={Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2.},
  author={Jennifer L. Spratlin and Roger B. Cohen and Matthew J Eadens and Lia Gore and D. Ross Camidge and Sami G. Diab and Stephen Leong and Cindy L. O’Bryant and Laura Q. M. Chow and Natalie J. Serkova and Neal J. Meropol and Nancy L. Lewis and E. Gabriela Chiorean and Floyd E. Fox and Hagop Youssoufian and Eric K. Rowinsky and S. Gail Eckhardt},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2010},
  volume={28 5},
  pages={
          780-7
        }
}
  • J. Spratlin, R. Cohen, +14 authors S. Eckhardt
  • Published 2010
  • Medicine
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology
PURPOSE To evaluate the safety, maximum-tolerated dose (MTD), pharmacokinetics (PKs), pharmacodynamics, and preliminary anticancer activity of ramucirumab (IMC-1121B), a fully human immunoglobulin G(1) monoclonal antibody targeting the vascular endothelial growth factor receptor (VEGFR)-2. PATIENTS AND METHODS Patients with advanced solid malignancies were treated once weekly with escalating doses of ramucirumab. Blood was sampled for PK studies throughout treatment. The effects of ramucirumab… Expand
Phase I study of every 2- or 3-week dosing of ramucirumab, a human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2 in patients with advanced solid tumors.
TLDR
Analysis of serum biomarkers indicated considerable patient-to-patient variability, but trends toward elevated VEGF-A and a transient decline in soluble VEGFR-2 were observed, suggesting ramucirumab efficacy in various solid tumors. Expand
Phase I trial and pharmacokinetic study of tanibirumab, a fully human monoclonal antibody to vascular endothelial growth factor receptor 2, in patients with refractory solid tumors
TLDR
Treatment with tanibirumab showed a tolerable toxicity profile and modest clinical efficacy in patients with refractory solid tumors. Expand
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TLDR
Ramucirumab monotherapy was well tolerated and feasible at the doses and schedules used in this study population of Japanese patients with advanced solid tumors. Expand
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TLDR
LY3022856 was well tolerated up to a dose of 30 mg/kg qwk, but with minimal anti-tumor activity in CRC, which is primarily mediated by the vascular endothelial growth factor receptor 3 (VEGFR-3). Expand
A Phase II and Biomarker Study of Ramucirumab, a Human Monoclonal Antibody Targeting the VEGF Receptor-2, as First-Line Monotherapy in Patients with Advanced Hepatocellular Cancer
TLDR
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Safety and Pharmacokinetics of Second-line Ramucirumab plus FOLFIRI in Japanese Patients with Metastatic Colorectal Carcinoma.
TLDR
Ramucirumab plus FOLFIRI was well-tolerated in Japanese patients with mCRC, warranting further investigation of this combination therapy. Expand
Ramucirumab: A vascular endothelial growth factor receptor-2 inhibitor with activity in several malignancies.
  • J. Grabowski, A. Glode
  • Medicine
  • American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
  • 2016
TLDR
Ramucirumab has demonstrated benefit in a variety of cancers, supporting the role of antiangiogenic agents in the management of malignancies, however, the clinical benefit in certain malignancy may be offset by the high cost of ramucorumab and the duration of treatment. Expand
Phase II Study Evaluating the Effect of Concomitant Ramucirumab on the Pharmacokinetics of Docetaxel in Patients with Advanced Solid Tumors
TLDR
Coadministration of ramucirumab had no effect on the pharmacokinetic parameters of docetaxel, and the incidence and severity of treatment-emergent adverse events were consistent with the known safety profiles of docentaxel and ramucorumab. Expand
A phase 2 randomised study of ramucirumab (IMC-1121B) with or without dacarbazine in patients with metastatic melanoma.
TLDR
Ramucirumab alone or in combination with dacarbazine was associated with an acceptable safety profile in patients with MM and PFS appeared greater with combination therapy, although the study was not powered for comparison between treatment arms. Expand
Safety and pharmacokinetics of ramucirumab in combination with docetaxel in Japanese patients with locally advanced or metastatic breast cancer: a Phase Ib study.
TLDR
The combination of ramucirumab and docetaxel was tolerable in female Japanese patients with metastatic/locally advanced breast cancer, supporting its use in future studies. Expand
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