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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The main purpose of this study is to see primarily if BYL719 is safe to be given to patients in combination with gemcitabine and nab-paclitaxel. Gemcitabine and nab-paclitaxel is an FDA-approved regimen to treat pancreatic cancer. Secondary goals will be to find out the effect on tumor of this new drug combination of BYL719, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of BYL719 will be tested. In the second part of the study, all patients will be started at the same dose of BYL719.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy: BYL719, Gemcitabine, (Nab)-Paciltaxel | Experimental | Dose escalation, followed by expansion, of BYL719 in combination with Gemcitabine and (Nab)-Paclitaxel. BYL719: once daily. Gemcitabine: Days 1,8, 15 of 28-day cycle. (Nab)-Paclitaxel: Days 1,8, 15 of 28-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BYL719 | Drug | Dose escalation beginning at 250 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) | The MTD is defined as the highest dose level at which one or none of 6 patients experience a Dose Limiting Toxicity (DLT). | Up to 4 months per participant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Complete Response plus Partial Response (CR+PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Kim, M.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| C585539 | Alpelisib |
| D000093542 | Gemcitabine |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Gemcitabine | Drug | Dose escalation beginning at 800 mg/m^2 |
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| (nab)-paclitaxel | Drug | 125 mg/m^2 dose |
|
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| Overall Survival (OS) | Overall survival of patients who receive at least one dose of the study drug at MTD. | Up to 3 years |
| Progression-Free Survival (PFS) | PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). | Up to 3 years |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |