A Study of LY2090314 and Chemotherapy in Participants With Metastatic Pancreatic Cancer
NCT ID: NCT01632306
Last Updated: 2019-01-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
13 participants
INTERVENTIONAL
2013-03-31
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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/m\^2) gemcitabine given IV on days 1, 8 and 15. Cohort closed to new enrollment per protocol addendum.
LY2090314
LY2090314 administered IV
Gemcitabine
Gemcitabine administered IV
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.
LY2090314
LY2090314 administered IV
FOLFOX
FOLFOX administered IV
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/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.
LY2090314
LY2090314 administered IV
Gemcitabine
Gemcitabine administered IV
Nab-paclitaxel
Nab-paclitaxel administered IV
Interventions
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LY2090314
LY2090314 administered IV
FOLFOX
FOLFOX administered IV
Gemcitabine
Gemcitabine administered IV
Nab-paclitaxel
Nab-paclitaxel administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to provide tissue and blood samples for research purposes
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Exclusion Criteria
* Prior cytotoxic chemotherapy for metastatic disease, except prior gemcitabine or FOLFIRINOX (5FU + leucovorin + irinotecan + oxaliplatin)
* Radiation therapy, immunotherapy or biologic therapy \<28 days prior to study entry
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
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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Mayo Clinic of Jacksonville
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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I2H-MC-JWYD
Identifier Type: OTHER
Identifier Source: secondary_id
14453
Identifier Type: -
Identifier Source: org_study_id
NCT01671202
Identifier Type: -
Identifier Source: nct_alias
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