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| Name | Class |
|---|---|
| Technostat | UNKNOWN |
| Novatrials | UNKNOWN |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TL-118 with standard of care Gemcitabine | Experimental |
| |
| Gemcitabine with out TL-118 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TL-118 | Drug | TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Measured at week 16 | |
| Quality of life | Baseline to study completion | |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Clinic | Atlanta | Georgia | 30322 | United States | ||
| White Plains Hospital |
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| Gemcitabine | Drug | Monthly cycles of 3 weekly treatments a month and one week off of treatment |
|
|
| Measured at week 16 and 52 |
| Overall Survival | Measured at week 16 and 52 |
| White Plains |
| New York |
| 10601 |
| United States |
| Assaf Harofe Medical Center | Ẕerifin | Zerifin | 70300 | Israel |
| HaEmek Medical Center | Afula | Israel |
| Soroka Medical Center | Beersheba | Israel |
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
| Rambam Medical Center | Haifa | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Sheba Medical Center | Ramat Gan | Israel |
| Sourasky Medical Center | Tel Aviv | Israel |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C575718 | TL-118 |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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