| ID | Type | Description | Link |
|---|---|---|---|
| I2H-MC-JWYD | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Study has been terminated due to slow enrollment.
Not provided
| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2090314 + Gemcitabine | Experimental | LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum. |
|
| LY2090314 + FOLFOX | Experimental | LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle. |
|
| LY2090314 + Gemcitabine + Nab-paclitaxel | Experimental | LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m^2 gemcitabine + 125 mg/m^2 nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2090314 | Drug | LY2090314 administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation | Change in the phosphorylation level of glycogen synthase, a glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, from baseline to 4 hours post-treatment on day 0 using tumor tissue and blood specimens. | Baseline, 4 Hours Post-Treatment on Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Baseline to Date of Death Due to any Cause Up to 21 Months | |
| Percentage of Participants Who Survived at 6 Months | Baseline to Date of Death to any cause Up to 6 Months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic of Jacksonville | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LY2090314 + Gemcitabine | LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m²) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum. |
| FG001 | LY2090314 + FOLFOX | LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle. |
| FG002 | LY2090314 + Gemcitabine + Nab-paclitaxel | LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 mg/m² gemcitabine + 125 mg/m² nab-paclitaxel given IV on days 1, 8 and 15 in 28-day cycle. New cohort opened per protocol amendment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LY2090314 + Gemcitabine | LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m²) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation | Change in the phosphorylation level of glycogen synthase, a glycogen synthase kinase-3 beta (GSK-3beta) inhibitor, from baseline to 4 hours post-treatment on day 0 using tumor tissue and blood specimens. | Zero participants analyzed. GSK3β phosphorylation levels were not determined, and the primary endpoint was not examined as there wasn't viable tumor tissue for analysis. | Posted | Baseline, 4 Hours Post-Treatment on Day 0 |
|
Not provided
All participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LY2090314 + Gemcitabine | LY2090314 given intravenously (IV) on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), 8 and 15 in 28 day cycle in combination with 1000 milligram/square meter (mg/m²) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
Study was terminated due to slow enrollment. No participants were enrolled in arm LY2090314 + Gemcitabine + Nab-paclitaxel due to inability to enroll participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C584053 | 3-(9-fluoro-2-(piperidin-1-ylcarbonyl)-1,2,3,4-tetrahydro(1,4)diazepino(6,7,1-hi)indol-7-yl)-4-imidazo(1,2-a)pyridin-3-yl-1H-pyrrole-2,5-dione |
| C410216 | Folfox protocol |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D000093542 | Gemcitabine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FOLFOX | Drug | FOLFOX administered IV |
|
|
| Gemcitabine | Drug | Gemcitabine administered IV |
|
|
| Nab-paclitaxel | Drug | Nab-paclitaxel administered IV |
|
| Progression Free Survival (PFS) |
PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first. |
| Baseline to Disease Progression Up to 18 Months |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100. A CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. | Baseline Up to 6 Months |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| LY2090314 + FOLFOX |
LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| LY2090314 + FOLFOX |
LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle. |
|
| Secondary | Overall Survival (OS) | All the participants that received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Baseline to Date of Death Due to any Cause Up to 21 Months |
|
|
|
| Secondary | Percentage of Participants Who Survived at 6 Months | All participants who received at least one dose of study drug. | Posted | Number | 90% Confidence Interval | Percentage of participants | Baseline to Date of Death to any cause Up to 6 Months |
|
|
|
| Secondary | Progression Free Survival (PFS) | PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first. | All participants who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Months | Baseline to Disease Progression Up to 18 Months |
|
|
|
| Secondary | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] | Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameters. ORR calculated as: (sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100. A CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. | All participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline Up to 6 Months |
|
|
|
| 3 |
| 3 |
| 2 |
| 3 |
| EG001 | LY2090314 + FOLFOX | LY2090314 given IV on days 1 (at cycle 1 LY2090314 given on day 0 instead of day 1), and 15 in 28 day cycle in combination with FOLFOX (leucovorin + 5-fluorouracil + oxaliplatin) given IV, on days 1 and 15 in 28 day cycle. | 7 | 10 | 10 | 10 |
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Gallbladder obstruction | Hepatobiliary disorders | CTCAE 4.0 | Systematic Assessment |
|
| Gastric fistula | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Failure to Thrive | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
|
| Clostridium difficle infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Peritoneal infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Thromboembolic event | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | CTCAE 4.0 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Alanine aminotransferase | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE 4.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE 4.0 | Systematic Assessment |
|
| Cardiac troponin T increased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Cognitive disturbance | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Creatinine increased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| ECG QT corrected interval prolonged | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Edema trunk | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| night sweats | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
|
| Elevated lactic acid | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Mucosal infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Death due to disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE 4.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Pain | General disorders | CTCAE 4.0 | Systematic Assessment |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Sinus disorder | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| White blood cell | Investigations | CTCAE 4.0 | Systematic Assessment |
|
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011621 |
| Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |