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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
170
OQL011 is an ointment containing active ingredient.
Vehicle ointment is an ointment containing no active ingredient.
(For Part 1) Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0 or 1 OR (for Part 2) The proportion of patients achieving IGA-HFSR grade 0 or 1
Time frame: 3 weeks (Part 1) OR 2 weeks (Part 2)
(For Part 1) Proportion of patients who have improvement in HFSR severity and achieve clear (0) or almost clear (1) as measured by IGA-i (Investigator-assessed Investigator's Global Assessment) scale
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Time frame: 3 weeks and 6 weeks
(For Part 2) Proportion of patients achieving IGA-HFSR grade 0 or 1
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Time frame: 4 weeks
(For Part 2) Proportion of patients achieving at least two-grade improvement in IGA-HFSR
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Time frame: 2 weeks and 4 weeks
(For Part 1) Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0 or 1
Time frame: 6 weeks
(For Part 2) Change from baseline in NCI CTCAE v5.0 - PPE grade
Time frame: 2 weeks and 4 weeks
Change from baseline in HF-QoL (Hand-Foot Skin Reaction and Quality of Life) Questionnaire total score
HF-QoL questionnaire is comprised of a 20-item symptom domain and an 18-item daily activity domain. Each item is rated on a 5-point scale from 0 (not at all) to 4 (always or extremely) during the previous week. The HF-QoL symptom and daily activity total scores are transformed to a scale of 0 to 100, based on the sum of each unit-weighted item score divided by the maximum score. Higher scores on the HF-QoL indicate worse quality of life or greater symptom burden. (refer to R. T. Anderson et al., The Oncologist 2015;20:831-838)
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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
St Louis, Missouri, United States
Innovative Clinical Research Institute
Henderson, Nevada, United States
...and 23 more locations
Time frame: 3 weeks and 6 weeks (Part 1) OR 2 weeks and 4 weeks (Part 2)
(For Part 1) Change from baseline in patient reported pain using VAS (Visual Analog Scale)
The subject records pain associated with HFSR using 100 mm VAS ranging from "no pain" at 0 mm to "unbearable pain" at 100 mm on the paper VAS.
Time frame: 3 weeks and 6 weeks
(For Part 2) Change from baseline in patient reported pain using NPRS (Numerical Pain Rating Scale)
The subject records pain associated with HFSR using score 0 to 10 ranging from "no pain" for Score 0 to "unbearable pain" for Score 10.
Time frame: 2 weeks and 4 weeks
(For Part 1) Proportion of patients who have improvement in HFSR severity and achieve clear (0) or almost clear (1) as measured by IGA-c (Centrally-assessed Investigator's Global Assessment) scale
The IGA scale ranges from grade 0 (clear) to 4 (severe), the higher the score, the worse the condition.
Time frame: 3 weeks and 6 weeks
Safety assessment by type, incidence and intensity of adverse events
Time frame: 6 weeks (Part 1) and 4 weeks (Part 2)
Plasma concentration of active compound and its derivatives
Time frame: 1 day
(For Part 2) The exposure-response relationship of different dose level OQL011
Time frame: 4 weeks