A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
NCT ID: NCT03086369
Last Updated: 2022-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
184 participants
INTERVENTIONAL
2017-06-22
2021-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine
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.
Olaratumab
Administered IV
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
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.
Olaratumab
Administered IV
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine
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.
Olaratumab
Administered IV
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine
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.
Olaratumab
Administered IV
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine
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.
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
Placebo
Administered IV
Interventions
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Olaratumab
Administered IV
Nab-paclitaxel
Administered IV
Gemcitabine
Administered IV
Placebo
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Comprehensive Blood and Cancer Center
Bakersfield, California, United States
St Jude Medical Center
Fullerton, California, United States
TRIO - Translational Research in Oncology-US, Inc.
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Cancer Center of Santa Barbara with Sansum Clinic
Santa Barbara, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Fort Wayne Oncology & Hematology
Fort Wayne, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Monter Cancer Center
Lake Success, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Sanford Research/USD
Sioux Falls, South Dakota, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Univ of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, United States
Charité Campus Virchow-Klinikum
Berlin, , Germany
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Other Identifiers
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I5B-MC-JGDP
Identifier Type: OTHER
Identifier Source: secondary_id
2016-001099-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15844
Identifier Type: -
Identifier Source: org_study_id
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