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Trial record 92 of 851 for:    Pancreatic Cancer AND Metastatic Pancreatic Cancer

A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632306
Recruitment Status : Terminated (Study has been terminated due to slow enrollment.)
First Posted : July 2, 2012
Results First Posted : November 19, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: LY2090314
Drug: FOLFOX
Drug: Gemcitabine
Drug: Nab-paclitaxel
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX LY2090314 + Gemcitabine + Nab-paclitaxel
Hide Arm/Group Description 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. 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 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.
Period Title: Overall Study
Started 3 10 0
Received at Least One Dose of Study Drug 3 10 0
Completed 2 10 0
Not Completed 1 0 0
Reason Not Completed
Protocol Violation             1             0             0
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 3 10 13
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 10 participants 13 participants
60.7  (8.5) 64.0  (4.9) 63.2  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 10 participants 13 participants
Female
1
  33.3%
4
  40.0%
5
  38.5%
Male
2
  66.7%
6
  60.0%
8
  61.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 10 participants 13 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
8
  80.0%
11
  84.6%
Unknown or Not Reported
0
   0.0%
2
  20.0%
2
  15.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 10 participants 13 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
9
  90.0%
12
  92.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  10.0%
1
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 10 participants 13 participants
3 10 13
1.Primary Outcome
Title Change From Baseline to 4 Hours Post-Treatment on Day 0 in Glycogen Synthase Phosphorylation
Hide Description 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.
Time Frame Baseline, 4 Hours Post-Treatment on Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Baseline to Date of Death Due to any Cause Up to 21 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All the participants that received at least one dose of study drug.
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 3 10
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.3 to 1.9)
7.7
(2.9 to 21.2)
3.Secondary Outcome
Title Percentage of Participants Who Survived at 6 Months
Hide Description [Not Specified]
Time Frame Baseline to Date of Death to any cause Up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 3 10
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0 to 0)
50.0
(26.9 to 92.9)
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description PFS was as the time from enrollment to the earliest documented evidence of disease progression or death,whatever comes first.
Time Frame Baseline to Disease Progression Up to 18 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 3 10
Median (95% Confidence Interval)
Unit of Measure: Months
1.8
(1.3 to 1.9)
3.4
(2.3 to 17.5)
5.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Hide Description

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.

Time Frame Baseline Up to 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 3 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
0 [1] 
(NA to NA)
10.0
(0.3 to 44.5)
[1]
There were "0" participants with CR or PR.
Time Frame [Not Specified]
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title LY2090314 + Gemcitabine LY2090314 + FOLFOX
Hide Arm/Group Description 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. 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.
All-Cause Mortality
LY2090314 + Gemcitabine LY2090314 + FOLFOX
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2090314 + Gemcitabine LY2090314 + FOLFOX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      7/10 (70.00%)    
Blood and lymphatic system disorders     
Anemia  1  1/3 (33.33%)  1 1/10 (10.00%)  1
Gastrointestinal disorders     
Abdominal pain  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Ascites  1  1/3 (33.33%)  1 1/10 (10.00%)  1
Colitis  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Diarrhea  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Gastric fistula  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Small intestinal obstruction  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/3 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Failure to Thrive  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Hepatobiliary disorders     
Gallbladder obstruction  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations     
Clostridium difficle infection  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Lung infection  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Peritoneal infection  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Sepsis  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Skin infection  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Investigations     
Neutrophil count decreased  1  0/3 (0.00%)  0 2/10 (20.00%)  3
Platelet count decreased  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Metabolism and nutrition disorders     
Anorexia  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Dehydration  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Hypophosphatemia  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
Hypotension  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Thromboembolic event  1  0/3 (0.00%)  0 1/10 (10.00%)  3
Pulmonary embolism  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2090314 + Gemcitabine LY2090314 + FOLFOX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      10/10 (100.00%)    
Blood and lymphatic system disorders     
Anemia  1  1/3 (33.33%)  1 2/10 (20.00%)  3
Endocrine disorders     
Adrenal insufficiency  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Eye disorders     
Blurred vision  1  0/3 (0.00%)  0 1/10 (10.00%)  6
Gastrointestinal disorders     
Abdominal pain  1  2/3 (66.67%)  2 8/10 (80.00%)  25
Ascites  1  0/3 (0.00%)  0 2/10 (20.00%)  4
Bloating  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Colitis  1  0/3 (0.00%)  0 1/10 (10.00%)  2
Constipation  1  0/3 (0.00%)  0 3/10 (30.00%)  13
Diarrhea  1  1/3 (33.33%)  1 4/10 (40.00%)  14
Esophageal pain  1  0/3 (0.00%)  0 2/10 (20.00%)  2
Flatulence  1  0/3 (0.00%)  0 2/10 (20.00%)  8
Gastritis  1  0/3 (0.00%)  0 1/10 (10.00%)  2
Gastroesophageal reflux disease  1  0/3 (0.00%)  0 2/10 (20.00%)  9
Mucositis oral  1  0/3 (0.00%)  0 3/10 (30.00%)  9
Nausea  1  2/3 (66.67%)  2 6/10 (60.00%)  26
Vomiting  1  1/3 (33.33%)  1 1/10 (10.00%)  8
General disorders     
Edema limbs  1  0/3 (0.00%)  0 1/10 (10.00%)  2
Edema trunk  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Fatigue  1  0/3 (0.00%)  0 9/10 (90.00%)  30
Fever  1  1/3 (33.33%)  1 1/10 (10.00%)  4
night sweats  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Pain  1  0/3 (0.00%)  0 2/10 (20.00%)  3
Immune system disorders     
Allergic reaction  1  0/3 (0.00%)  0 1/10 (10.00%)  2
Infections and infestations     
Mucosal infection  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Investigations     
Alanine aminotransferase  1  1/3 (33.33%)  1 4/10 (40.00%)  11
Alkaline phosphatase  1  0/3 (0.00%)  0 3/10 (30.00%)  7
Aspartate aminotransferase increased  1  1/3 (33.33%)  1 4/10 (40.00%)  8
Blood bilirubin increased  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Cardiac troponin T increased  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Creatinine increased  1  0/3 (0.00%)  0 1/10 (10.00%)  2
ECG QT corrected interval prolonged  1  1/3 (33.33%)  1 5/10 (50.00%)  5
Elevated lactic acid  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Neutrophil count decreased  1  0/3 (0.00%)  0 3/10 (30.00%)  10
Platelet count decreased  1  0/3 (0.00%)  0 5/10 (50.00%)  23
White blood cell  1  0/3 (0.00%)  0 1/10 (10.00%)  6
Metabolism and nutrition disorders     
Anorexia  1  1/3 (33.33%)  1 4/10 (40.00%)  14
Dehydration  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Hyperglycemia  1  0/3 (0.00%)  0 1/10 (10.00%)  7
Hypoalbuminemia  1  1/3 (33.33%)  1 1/10 (10.00%)  1
Hypocalcemia  1  0/3 (0.00%)  0 2/10 (20.00%)  8
Hypoglycemia  1  0/3 (0.00%)  0 1/10 (10.00%)  2
Hypokalemia  1  0/3 (0.00%)  0 2/10 (20.00%)  5
Hypomagnesemia  1  0/3 (0.00%)  0 2/10 (20.00%)  8
Hyponatremia  1  0/3 (0.00%)  0 2/10 (20.00%)  3
Musculoskeletal and connective tissue disorders     
Arthritis  1  0/3 (0.00%)  0 1/10 (10.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Death due to disease progression  1  1/3 (33.33%)  1 0/10 (0.00%)  0
Nervous system disorders     
Akathisia  1  0/3 (0.00%)  0 1/10 (10.00%)  7
Cognitive disturbance  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Dizziness  1  0/3 (0.00%)  0 1/10 (10.00%)  7
Dysgeusia  1  0/3 (0.00%)  0 2/10 (20.00%)  10
Headache  1  0/3 (0.00%)  0 1/10 (10.00%)  2
Dysgeusia  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Headache  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Peripheral motor neuropathy  1  0/3 (0.00%)  0 1/10 (10.00%)  7
Peripheral sensory neuropathy  1  0/3 (0.00%)  0 4/10 (40.00%)  21
Psychiatric disorders     
Anxiety  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  0/3 (0.00%)  0 1/10 (10.00%)  6
Cough  1  0/3 (0.00%)  0 1/10 (10.00%)  5
Dyspnea  1  1/3 (33.33%)  1 2/10 (20.00%)  9
Sinus disorder  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Skin and subcutaneous tissue disorders     
Alopecia  1  0/3 (0.00%)  0 3/10 (30.00%)  6
Skin ulceration  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Vascular disorders     
Hypotension  1  0/3 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 4.0
Study was terminated due to slow enrollment. No participants were enrolled in arm LY2090314 + Gemcitabine + Nab-paclitaxel due to inability to enroll participants.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01632306     History of Changes
Obsolete Identifiers: NCT01671202
Other Study ID Numbers: 14453
I2H-MC-JWYD ( Other Identifier: Eli Lilly and Company )
First Submitted: June 28, 2012
First Posted: July 2, 2012
Results First Submitted: October 17, 2018
Results First Posted: November 19, 2018
Last Update Posted: January 15, 2019