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The purpose of this study is to evaluate the efficacy, safety and tolerability of TL-118 alone or in combination with pancreatic cancer chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TL-118 alone or with pancreas cancer chemotherapy | Experimental |
|
| 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 |
|---|---|---|
| Clinical Benefit Measurement | Clinical Benefit Measurement is a composite of measurements of pain (analgesic consumption and pain intensity), performance status and weight. Clinical benefit requires an improvement in at least one parameter, without worsening in any others, sustained for at least 4 weeks | Baseline up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Safety and tolerability profiles will be judged by:
| Baseline up to 2 years |
| Response Rate (RR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ayala Huberrt, MD | Contact | AyalaH@hadassah.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Center | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C575718 | TL-118 |
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| RR measured every 8 weeks after enrollment up to 2 years |
| Overall Survival | OS measured at 16 and 52 weeks after treatment initiation or at death, whichever comes first up to 2 years |
| Progression Free Survival (PFS) | PFS measured at 8 weeks after enrollment until the date of first documented progression or date of death, whichever comes first, up to 2 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |