Surrogate Markers for Antiangiogenic Therapy and Dose-Limiting Toxicities for Bevacizumab With Radiation and Chemotherapy: Continued Experience of a Phase I Trial in Rectal Cancer Patients

2005 ◽  
Vol 23 (31) ◽  
pp. 8136-8139 ◽  
Author(s):  
Christopher G. Willett ◽  
Yves Boucher ◽  
Dan G. Duda ◽  
Emmanuelle di Tomaso ◽  
Lance L. Munn ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Antiangiogenic Therapy ◽  
Surrogate Markers

Phase I-trial of a methotrexate — Albumin conjugate (MTX-HSA) in cancer patients

1997 ◽  
Vol 33 ◽  
pp. S249-S250 ◽  
Author(s):  
G. Hartung ◽  
G. Stehle ◽  
H. Sinn ◽  
H.H. Schrenk ◽  
S. Heeger ◽  
...  
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial

Phase I trial of the thioether phospholipid analogue BM 41.440 in cancer patients

Lipids ◽  
1987 ◽  
Vol 22 (11) ◽  
pp. 962-966 ◽  
Author(s):  
Dieter B. J. Herrmann ◽  
Herbert A. Neumann ◽  
Wolfgang E. Berdel ◽  
Manfred E. Heim ◽  
Michael Fromm ◽  
...  
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial

PHASE I TRIAL OF MURINE ANTI-GANGLIOSIDE (GD2) MONOCLONAL ANTIBODY (Mab) 14G2A IN CANCER PATIENTS

1992 ◽  
Vol 11 (2) ◽  
pp. 135 ◽  
Author(s):  
J. L. Murray ◽  
J. E. Cunningham ◽  
H. M. Brewer ◽  
M. H. Janus ◽  
D. A. Podoloff ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Ganglioside Gd2

scholarly journals A Phase I Trial of a Guadecitabine (SGI-110) and Irinotecan in Metastatic Colorectal Cancer Patients Previously Exposed to Irinotecan

2018 ◽  
Vol 24 (24) ◽  
pp. 6160-6167 ◽  
Author(s):  
Valerie Lee ◽  
Judy Wang ◽  
Marianna Zahurak ◽  
Elske Gootjes ◽  
Henk M. Verheul ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase I ◽  
Metastatic Colorectal Cancer ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Colorectal Cancer Patients

scholarly journals First-in-human phase I trial of anti-hepatocyte growth factor antibody (YYB101) in refractory solid tumor patients

2020 ◽  
Vol 12 ◽  
pp. 175883592092679
Author(s):  
Seung Tae Kim ◽  
Jung Yong Hong ◽  
Se Hoon Park ◽  
Joon Oh Park ◽  
Young Whan Park ◽  
...  
Keyword(s):  
Growth Factor ◽  
Hepatocyte Growth Factor ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Maximum Tolerated Dose ◽  
Safety And Efficacy ◽  
Hepatocyte Growth

Background: YYB101, a humanized monoclonal antibody against hepatocyte growth factor (HGF), has shown safety and efficacy in vitro and in vivo. This is a first-in-human trial of this antibody. Materials and Methods: YYB101 was administered intravenously to refractory cancer patients once every 4 weeks for 1 month, and then once every 2 weeks until disease progression or intolerable toxicity, at doses of 0.3, 1, 3, 5, 10, 20, 30 mg/kg, according to a 3+3 dose escalation design. Maximum tolerated dose, safety, pharmacokinetics, and pharmacodynamics were studied. HGF, MET, PD-L1, and ERK expression was evaluated for 9 of 17 patients of the expansion cohort (20 mg/kg). Results: In 39 patients enrolled, no dose-limiting toxicity was observed at 0.3 mg/kg, and the most commonly detected toxicity was generalized edema ( n = 7, 18.9%) followed by pruritis and nausea ( n = 5, 13.5%, each), fatigue, anemia, and decreased appetite ( n = 4, 10.8%, each). No patient discontinued treatment because of adverse events. YYB101 showed dose-proportional pharmacokinetics up to 30 mg/kg. Partial response in 1 (2.5%) and stable disease in 17 (43.5%) were observed. HGF, MET, PD-L1, and ERK proteins were not significant predictors for treatment response. However, serum HGF level was significantly lowered in responders upon drug administration. RNA sequencing revealed a mesenchymal signature in two long-term responders. Conclusion: YYB101 showed favorable safety and efficacy in patients with refractory solid tumors. Based on this phase I trial, a phase II study on the YYB101 + irinotecan combination in refractory metastatic colorectal cancer patients is planned. Conclusion: ClinicalTrials.gov Identifier: NCT02499224

P3-11-03: A Phase I Trial of D-Limonene in Newly Diagnosed Breast Cancer Patients: A Chemoprevention Study.

2011 ◽  
Author(s):  
JE Lang ◽  
JA Miller ◽  
BT Nokes ◽  
LG LeBeau ◽  
M Delbridge ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Newly Diagnosed ◽  
Breast Cancer Patients
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