Affirm study aflibercept

Aflibercept - ncbi.nlm.nih.gov

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4/15/2013 · To investigate the potential role of aflibercept in the first-line treatment of mCRC with chemotherapy, the phase II AFFIRM trial (Study of Aflibercept and Modified FOLFOX6 as First-Line Treatment in Patients with Metastatic Colorectal Cancer) evaluated the efficacy of aflibercept in combination with 5-fluorouracil, leucovorin, and oxaliplatin ...

Aflibercept - ncbi.nlm.nih.gov

Aflibercept in the treatment of patients with metastatic ...

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The AFFIRM trial (Study of Aflibercept and Modified FOLFOX6 as First-Line Treatment in Patients with Metastatic Colorectal Cancer) randomized 236 chemotherapy-naïve patients with MCRC to FOLFOX with or without aflibercept given at 4 mg/kg [ClinicalTrials.gov identifier: NCT00851084] (Table 2) [Pericay et al. 2012]. The primary endpoint of this ...

Aflibercept in the treatment of patients with metastatic ...

Study of Aflibercept And Modified FOLFOX6 As First-Line ...

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Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer (AFFIRM) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Study of Aflibercept And Modified FOLFOX6 As First-Line ...

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

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To investigate the potential role of aflibercept in the first-line treatment of mCRC with chemotherapy, the phase II AFFIRM trial (Study of Aflibercept and Modified FOLFOX6 as First-Line Treatment in Patients with Metastatic Colorectal Cancer) evaluated the efficacy of aflibercept in combination with 5-fluorouracil, leucovorin, and oxaliplatin ...

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

Aflibercept | Clinical Cancer Research

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In the AFFIRM study, the addition of aflibercept to mFOLFOX6 did not demonstrate a benefit in first-line therapy in patients with mCRC but higher toxicity. Abstract . View article; Supplementary data; Tags: aflibercept, colorectal cancer metastatic, oxaliplatin, affirm study, affirm study.

Aflibercept | Clinical Cancer Research

Volume 27 Issue 7 | Annals of Oncology | Oxford Academic

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Multiple Angiogenic Factor Trap 1-3 Inhibits angiogenesis by trapping VEGF-A, VEGF-B, and P L GF, factors implicated in the angiogenic process* 1-3 ZALTRAP ® (ziv-aflibercept) inhibited multiple angiogenic factors in preclinical studies* 1-3 *The clinical significance is unknown. Angiogenesis is a complex process controlled by VEGF-A, as well as a network of signaling molecules and pathways 6,7

Volume 27 Issue 7 | Annals of Oncology | Oxford Academic

Mechanism of Action | ZALTRAP® (ziv-aflibercept)

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11/1/2012 · Purpose: Aflibercept is a recombinant fusion protein of the VEGF receptor (VEGFR) 1 and VEGFR2 extracellular domains. We assessed the safety and efficacy of aflibercept in patients with metastatic colorectal cancer (MCRC) who had received at least one prior palliative regimen. Experimental Design: Seventy-five patients were enrolled onto this two-stage phase II trial in two cohorts ...

Mechanism of Action | ZALTRAP® (ziv-aflibercept)

Phase II Clinical and Pharmacokinetic Study of Aflibercept ...

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9/10/2015 · AFFIRM was an open-label, non-comparative, phase II study conducted to assess the combination of aflibercept and mFOLFOX6 given as first-line therapy in patients with mCRC.

Phase II Clinical and Pharmacokinetic Study of Aflibercept ...

Evaluation of efficacy and safety markers in a phase II ...

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In addition, a randomized Phase 2 study (AFFIRM) is evaluating aflibercept as a 1st line treatment for metastatic colorectal cancer in combination with FOLFOX (folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin). The AFFIRM study is fully enrolled, and initial data are anticipated in the second half of 2011. Source: press release, 4/29/10.

Evaluation of efficacy and safety markers in a phase II ...

Regeneron aflibercept colorectal II AFFIRM | Biotechnology ...

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Eylea PowerPoint 1. Eylea (Aflibercept) Pitt Street Health Plan P & T Committee ... Primary Endpoint Results Study Group VIEW 1 VIEW 2 Aflibercept 2mg every 4 weeks 95.1% 95.6% Aflibercept 0.5mg every 4 weeks 95.9% 96.3% Aflibercept 2mg every 8 weeks 95.1% 95.7% Ranibizumab 0.5mg every 4 weeks 94.4% 94.4% *All results are at Week 52

Regeneron aflibercept colorectal II AFFIRM | Biotechnology ...

Eylea PowerPoint - SlideShare

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phase 2 randomized, noncomparative, open-label study of aflibercept and modified folfox6 in the first-line treatment of metastatic colorectal cancer (affirm)

Eylea PowerPoint - SlideShare

PHASE 2 RANDOMIZED, NONCOMPARATIVE, OPEN-LABEL STUDY …

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A preclinical and clinical review of aflibercept for the management of cancer. Author links open overlay panel Andrew Gaya Vivien Tse a. ... In a study of aflibercept administered subcutaneously at doses of 50–800 ... II AFFIRM: Aflibercept plus modified oxaliplatin plus 5-FU plus folinic acid (FOLFOX6) vs. modified FOLFOX6 alone ...

PHASE 2 RANDOMIZED, NONCOMPARATIVE, OPEN-LABEL STUDY …

A preclinical and clinical review of aflibercept for the ...

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Evaluation of efficacy and safety markers in a phase II study of metastatic colorectal cancer treated with aflibercept in the first-line setting ... phase II AFFIRM trial assessing aflibercept in ...

A preclinical and clinical review of aflibercept for the ...

(PDF) Evaluation of efficacy and safety markers in a phase ...

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The activity of aflibercept in chemonaive patients with mCRC was only studied in the context of a phase 2 study (AFFIRM), which randomized 236 patients to receive first-line therapy with mFOLFOX6 (oxaliplatin, leucovorin, and 5-FU) plus aflibercept or mFOLFOX6 alone.

(PDF) Evaluation of efficacy and safety markers in a phase ...

AMALTHEA: Prospective, Single-Arm Study of the Hellenic ...

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Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: The AFFIRM study. G. Folprecht, C. Pericay, M. P. Saunders, A. Thomas, R. Lopez Lopez, ...

AMALTHEA: Prospective, Single-Arm Study of the Hellenic ...

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

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Aflibercept in combination with 5‑fluorouracil (5‑FU)/irinotecan improves overall survival in the second‑line therapy of patients with metastatic colorectal cancer (mCRC). In this study, we evaluated the effects of aflibercept in first‑line therapy with FOLFOX followed by maintenance with fluoropyrimidine.

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

Efficacy of aflibercept with FOLFOX and maintenance with ...

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Inhibition of angiogenesis is an established adjunct in the treatment of metastatic colorectal cancer. Bevacizumab, a monoclonal antibody that binds to vascular endothelial growth factor (VEGF) A, improves clinical outcomes when added to standard chemotherapy for metastatic colorectal cancer. Unfortunately, the development of resistance is inevitable, and novel therapeutic strategies are needed.

Efficacy of aflibercept with FOLFOX and maintenance with ...

Aflibercept in the treatment of patients with metastatic ...

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5/1/2017 · Hypothesis generating data was produced initially in the phase II AFFIRM study (FOLFOX6 with or without aflibercept in first-line treatment of mCRC).16 The programme was expanded to include samples from the pivotal VELOUR study and another phase III study of aflibercept in Asian patients (with a similar design to the VELOUR study). The full ...

Aflibercept in the treatment of patients with metastatic ...

European Medicines Agency approval summary: Zaltrap for ...

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10/1/2013 · Ziv-aflibercept in metastatic colorectal cancer Anuj Patel, Weijing Sun Division of Hematology-Oncology, University of Pittsburgh Cancer Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA Abstract: The combination of cytotoxic chemotherapy and antiangiogenic agents has become a conventional treatment option for patients with metastatic colorectal cancer.

European Medicines Agency approval summary: Zaltrap for ...

[Full text] Ziv-aflibercept in metastatic colorectal ...

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Case Reports in Oncological Medicine is a peer-reviewed, Open Access journal that publishes case reports and case series related to breast cancer, lung cancer, gastrointestinal cancer, skin cancer, head and neck cancer, paediatric oncology, neurooncology as well as genitourinary cancer.

[Full text] Ziv-aflibercept in metastatic colorectal ...

Case Reports in Oncological Medicine - Hindawi

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This phase II trial will compare the efficacy, tolerability and immunogenicity of aflibercept and modified FOLFOX6 (oxaliplatin, fluorouracil and folinic acid) Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer.

Case Reports in Oncological Medicine - Hindawi

Randomized, Multinational, Study Of Aflibercept And ...

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View This Abstract Online; Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study.

Randomized, Multinational, Study Of Aflibercept And ...

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

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REVIEW Current and Novel Treatment Options for Metastatic Colorectal Cancer: Emphasis on Aflibercept Maria H. P. Dietvorst • Ferry A. L. M. Eskens To view enhanced content go to www.biologicstherapy-open.com

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

Current and Novel Treatment Options for Metastatic ...

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8/15/2012 · Ziv-Aflibercept Approved as 2nd line treatment for metastatic CRC For the first time in more than five years, the FDA has approved a new drug for certain patients who have metastatic colorectal cancer. The FDA has approved ZALTRAP® (ziv-aflibercept) to be used with FOLFIRI as...

Current and Novel Treatment Options for Metastatic ...

Ziv-Aflibercept gets FDA approval | Fight Colorectal Cancer

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F1000Prime Recommended Article: Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first-line treatment of patients with metastatic colorectal cancer: the AFFIRM study.

Ziv-Aflibercept gets FDA approval | Fight Colorectal Cancer

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

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12/31/2010 · In addition, a Phase 2 study (AFFIRM) of aflibercept in 1st-line metastatic colorectal cancer in combination with FOLFOX (folinic acid [leucovorin], 5-fluorouracil, and oxaliplatin) is also fully enrolled. ... Initial data from the AFFIRM study are anticipated in the second half of 2011.

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

regeneron_10k.htm - sec.gov

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4/18/2016 · Adding aflibercept to first-line mFOLFOX6 did not improve progression-free survival compared with mFOLFOX6 alone in patients with mCRC, …

regeneron_10k.htm - sec.gov

Adding Aflibercept to First-line mFOLFOX6 Does Not Improve ...

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pm133_ccc_ziv-aflibercept (zaltrap) 2 of 5 data contained in this document is considered confidential and proprietary information and its duplication use or disclosure is prohibited without prior approval of community health plan of washington.

Adding Aflibercept to First-line mFOLFOX6 Does Not Improve ...

REQUIRED CLINICAL DOCUMENTATION FOR REVIEW BACKGROUND

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Phase 3 Trial of ZALTRAP™ (aflibercept) in Advanced Prostate Cancer to Continue as Planned at Recommendation of Independent Data Monitoring Committee ... AFFIRM study (Phase 2): first-line ...

REQUIRED CLINICAL DOCUMENTATION FOR REVIEW BACKGROUND

Phase 3 Trial of ZALTRAP™ (aflibercept) in Advanced ...

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Aflibercept (ziv-aflibercept) is an anti-angiogenic agent recently approved in combination with FOLFIRI for the treatment of metastatic colorectal cancer (mCRC) patients previously treated with oxaliplatin. Despite heterogeneity in response to aflibercept, no biomarkers for efficacy or …

Phase 3 Trial of ZALTRAP™ (aflibercept) in Advanced ...

Metastatic Colorectal Cancer Treated With Aflibercept ...

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Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with or without aflibercept in first line treatment of patients with metastatic colorectal cancer - the AFFIRM study.

Metastatic Colorectal Cancer Treated With Aflibercept ...

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

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The main objective of the VELOUR (Aflibercept Versus Placebo in Combination with Irinotecan and 5-FU [FOLFIRI] in the Treatment of Patients with Metastatic Colorectal Cancer after Failure of an Oxaliplatin Based Regimen) study is to evaluate the safety and effectiveness of aflibercept as a second-line treatment in combination with folinic acid ...

Oxaliplatin and 5-FU/folinic acid (modified FOLFOX6) with ...

Phase 3 Trial Of Aflibercept In Second-Line Metastatic ...

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5/4/2017 · The present invention concerns the use of interleukin-8 (IL-8) as a biomarker for predicting the outcome of the treatment with aflibercept, or ziv-aflibercept of a patient suspected to suffer from a cancer.

Phase 3 Trial Of Aflibercept In Second-Line Metastatic ...

METHOD FOR PREDICTING THE OUTCOME OF A TREATMENT …

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In addition, a Phase 2 study (AFFIRM) of aflibercept in 1st-line metastatic colorectal cancer in combination with FOLFOX (folinic acid [leucovorin], 5-fluorouracil, and oxaliplatin) is also fully enrolled.

METHOD FOR PREDICTING THE OUTCOME OF A TREATMENT …

regeneron_10q.htm - SEC.gov

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7/7/2011 · Regeneron Pharmaceuticals, Inc. Release: Phase 3 Trial of ZALTRAP™ (aflibercept) in Advanced Prostate Cancer to Continue as Planned at Recommendation of Independent Data Monitoring Committee - read this article along with other careers information, tips and advice on BioSpace

regeneron_10q.htm - SEC.gov
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