Back to resultsA Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Primary Purpose
Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Olaratumab
Nab-paclitaxel
Gemcitabine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
- If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
- Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
- Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
- Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
- Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Discontinued all previous treatments for cancer ≥4 weeks prior.
- Adequate organ function.
- Life expectancy of at least 3 months.
Exclusion Criteria:
- Serious concomitant systemic disorder.
- Have received first line treatment for metastatic pancreatic cancer.
- Received prior treatment with nab-paclitaxel.
- Have known central nervous system malignancy or metastasis.
- Current hematologic malignancies.
- Participated within the last 30 days in a clinical trial involving an investigational product.
- Women with a positive pregnancy test or lactating.
- Have endocrine pancreatic tumors or ampullary cancer.
- Currently enrolled in another clinical trial.
- Have a known additional malignancy that is progressing or required active treatment within the past 1 year.
- Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
- Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.
Sites / Locations
- TGen Clinical Research Services at Scottsdale Healthcare
- University of Arizona Cancer Center
- Highlands Oncology Group
- Comprehensive Blood and Cancer Center
- St Jude Medical Center
- TRIO - Translational Research in Oncology-US, Inc.
- UCLA Medical Center
- Cancer Center of Santa Barbara with Sansum Clinic
- Central Coast Medical Oncology Corporation
- Smilow Cancer Hospital at Yale-New Haven
- Florida Cancer Specialists
- Florida Cancer Specialists and Research Institute
- H Lee Moffitt Cancer Center
- Fort Wayne Oncology & Hematology
- Cancer Center of Kansas
- Nebraska Methodist Hospital
- Comprehensive Cancer Centers of Nevada
- Dartmouth Hitchcock Medical Center
- Rutgers Cancer Institute of New Jersey
- Roswell Park Cancer Institute
- Monter Cancer Center
- Thomas Jefferson University
- UPMC Hillman Cancer Center
- Medical University of South Carolina
- Sanford Research/USD
- Chattanooga Oncology Hematology Associates
- Sarah Cannon Research Institute SCRI
- Tennessee Oncology PLLC
- Vanderbilt University Medical Center
- Univ of Texas Health Science Center at San Antonio
- University of Utah School of Medicine
- University of Wisconsin-Madison Hospital and Health Clinic
- Charité Campus Virchow-Klinikum
- Hospital Universitari Vall d'Hebron
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Arm Description
Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Outcomes
Primary Outcome Measures
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:
Any febrile neutropenia
Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage
Grade 4 neutropenia lasting 7 days or longer
Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.
Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
Phase 2: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Secondary Outcome Measures
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
PK: Cmin of olaratumab
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Phase 1b: Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Phase 2: Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Phase 1b/2: Duration of Response (DoR)
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03086369
Brief Title
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Official Title
A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2017 (Actual)
Primary Completion Date
January 5, 2021 (Actual)
Study Completion Date
June 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
Arm Type
Experimental
Arm Description
Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Arm Title
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
Arm Type
Experimental
Arm Description
Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Arm Title
Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
Arm Type
Experimental
Arm Description
Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Arm Title
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
Arm Type
Experimental
Arm Description
Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Arm Title
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
Arm Type
Placebo Comparator
Arm Description
Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
Intervention Type
Drug
Intervention Name(s)
Olaratumab
Other Intervention Name(s)
LY3012207
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
Description
A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:
Any febrile neutropenia
Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage
Grade 4 neutropenia lasting 7 days or longer
Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.
Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).
Time Frame
Cycle 1 (Up to 28 days)
Title
Phase 2: Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Time Frame
Baseline to Date of Death from Any Cause (Up To 29 Months)
Secondary Outcome Measure Information:
Title
Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab
Description
PK: Cmin of olaratumab
Time Frame
Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15
Title
Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Description
Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies
Time Frame
Baseline through Follow-up (Up To 29 Months)
Title
Phase 1b: Overall Survival (OS)
Description
OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.
Time Frame
Baseline to Date of Death from Any Cause (Approximately 9 Months)
Title
Phase 2: Progression-Free Survival (PFS)
Description
PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 [RECIST v.1.1]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.
Time Frame
Baseline to Disease Progression or Death (Up To 26 Months)
Title
Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Description
ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Time Frame
Baseline through Disease Progression or Death (Up To 26 Months)
Title
Phase 1b/2: Duration of Response (DoR)
Description
DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.
Time Frame
From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)
Title
Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"
Description
The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.
Time Frame
Baseline through Follow-up (Up To 21 Months)
Title
Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.
Description
The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.
Time Frame
Baseline through Follow-up (Up To 21 Months)
Title
Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)
Description
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Time Frame
Cycle 1 Day 1, Cycle 7 Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.
If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.
Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.
Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow.
Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.
Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Discontinued all previous treatments for cancer ≥4 weeks prior.
Adequate organ function.
Life expectancy of at least 3 months.
Exclusion Criteria:
Serious concomitant systemic disorder.
Have received first line treatment for metastatic pancreatic cancer.
Received prior treatment with nab-paclitaxel.
Have known central nervous system malignancy or metastasis.
Current hematologic malignancies.
Participated within the last 30 days in a clinical trial involving an investigational product.
Women with a positive pregnancy test or lactating.
Have endocrine pancreatic tumors or ampullary cancer.
Currently enrolled in another clinical trial.
Have a known additional malignancy that is progressing or required active treatment within the past 1 year.
Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.
Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
TGen Clinical Research Services at Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Comprehensive Blood and Cancer Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
St Jude Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
TRIO - Translational Research in Oncology-US, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cancer Center of Santa Barbara with Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Florida Cancer Specialists and Research Institute
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
H Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Fort Wayne Oncology & Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0001
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0002
Country
United States
Facility Name
Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232-1305
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sanford Research/USD
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Chattanooga Oncology Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Sarah Cannon Research Institute SCRI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
Univ of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah School of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Wisconsin-Madison Hospital and Health Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-4108
Country
United States
Facility Name
Charité Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
https://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/13wSI7GbbMae4kSSGsoWOw
Description
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Learn more about this trial
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
We'll reach out to this number within 24 hrs