TL-118 is an anti-angiogenic drug combination designed for the treatment of cancer. The investigational product Tl-118 comprises of four well-known active components. The therapy is administrated at a unique dosing regimen that was found to be effective and advantageous in terms of safety. The product is formulated as an oral suspension, conveniently administrated by the patients at home and not requiring medical staff assistance. This Phase II clinical trial aims to evaluate the efficacy, safety and tolerability of TL-118 in Gemcitabine treated Pancreatic Cancer patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles.
Monthly cycles of 3 weekly treatments a month and one week off of treatment
Emory Clinic
Atlanta, Georgia, United States
White Plains Hospital
White Plains, New York, United States
Assaf Harofe Medical Center
Ẕerifin, Zerifin, Israel
HaEmek Medical Center
Afula, Israel
Soroka Medical Center
Beersheba, Israel
Hillel Yaffe Medical Center
Hadera, Israel
Rambam Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Sourasky Medical Center
Tel Aviv, Israel
Disease Control Rate as defined by Percentage of patients experiencing a Complete Response or a Partial Response or a Stable Disease according to RECIST measured at 16 weeks after treatment initiation
Time frame: 16 weeks after treatment initiation
Response Rate
Time frame: Measured at week 16
Quality of life
Time frame: Baseline to study completion
Progression free survival
Time frame: Measured at week 16 and 52
Overall Survival
Time frame: Measured at week 16 and 52
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