A Clinical Trial of Anti-Angiogenic Drug Combination Tl-118 for Pancreatic Cancer Patients Who Are Starting Gemcitabine Treatment

Study Overview
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Brief Summary
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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

Conditions
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Metastatic Pancreatic Cancer

Intervention / Treatment
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* Drug: TL-118
* Drug: Gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 years at enrollment. Metastatic Pancreatic Cancer The patient has histologically or cytologically confirmed pancreatic adenocarcinoma. Patient has measurable disease by (RECIST). Patient is starting standard of care Gemcitabine treatment ECOG performance status ≤ 1 Adequate renal function Adequate hepatic function Adequate bone marrow reserve Resolution of prior therapy acute adverse events. Patient is capable of swallowing. Patient's Informed Consent. - Exclusion Criteria: Hypersensitivity to one or more of the TL-118 active components Known Glucose-6-phosphate-dehydrogenase deficiency (G6PD). CNS or Brain metastases Prior systemic therapy for pancreas cancer Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening Concurrent use of any other investigational product Subjects with a clinically significant or unstable medical condition that would preclude safe and complete study participation Use of supplements or complementary medicines/botanicals, except for conventional multivitamin supplements, calcium, selenium and soy supplements. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C Circumstances likely to interfere with absorption of orally administrated drugs. History of noncompliance to medical regimens or coexisting -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TL-118 with standard of care Gemcitabine<br> | Drug: TL-118<br>* TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles.<br>|
| Active Comparator: Gemcitabine with out TL-118<br> | Drug: Gemcitabine<br>* Monthly cycles of 3 weekly treatments a month and one week off of treatment<br>* Other names: Gemzar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 16 weeks after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | Measured at week 16 | 
| Quality of life |  | Baseline to study completion | 
| Progression free survival |  | Measured at week 16 and 52 | 
| Overall Survival |  | Measured at week 16 and 52 |