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Brief Title: A Study to Investigate OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
Official Title: A Phase II Study to Evaluate the Safety and Efficacy of OQL011 on VEGFR Inhibitor-Associated Hand-Foot Skin Reaction in Cancer Patients
Study ID: NCT04088318
Brief Summary: Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) treatment in cancer patients. The main purpose of this study is to evaluate the safety and efficacy of OQL011 compared to vehicle ointment in treating patients with moderate to severe VEGFRi-associated HFSR. This study will also identify an optimal dosage for Phase III study and explore the pharmacokinetics profile of OQL011 in HFSR patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Western Regional Medical Center, Goodyear, Arizona, United States
Innovative Clinical Research Institute, Whittier, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Yale University - Hospital, New Haven, Connecticut, United States
AP Medical Research, Miami, Florida, United States
Northwestern University - Hospital, Chicago, Illinois, United States
University of Louisville - Hospital, Louisville, Kentucky, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Innovative Clinical Research Institute, Henderson, Nevada, United States
Montefiore Einstein Center for Cancer Care, Bronx, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Gabrail Cancer Centre, Canton, Ohio, United States
Ohio State University Dermatology, Columbus, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Nantong Tumor Hospital, Nantong, Jiangsu, China
Taizhou People's Hospital, Taizhou, Jiangsu, China
Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai, China
Tongren Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Shanghai Tenth People's Hospital, Shanghai, Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, China
Shanghai Sixth People's Hospital, Shanghai, Shanghai, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
S.P Medical College & AG Hospitals, Bikaner, Bīkaner, Dimhans, India
Kiran Multi Super Speciality Hospital & Research Center, Sūrat, Gujarat, India
Kailash Cancer Hospital and Research Center, Vadodara, Gujarat, India
Aadhar Health Institute, Hisar, Haryana, India
Noble Hospital, Pune, Hisar, Haryana, India
Oncoville Cancer Hospital and Research Center, Bangalore, Karnataka, India
Mumbai Oncocare Centre, Mumbai, Maharashtra, India
HCG Manavata Cancer centre, Nashik, Naka, Nashik, India
Name: Mario E. Lacouture, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR