Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:March 1, 2017
End Date:March 31, 2020
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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Randomized Study of AM0010 in Combination With FOLFOX Compared to FOLFOX Alone as Second-line Tx in Pts With Meta Pancreatic Cancer That Has Progressed During or Following a First-Line Gemcitabine Containing Regimen

To compare the efficacy of pegilodecakin in combination with FOLFOX versus FOLFOX alone in
participants with metastatic pancreatic cancer as measured by overall survival.

This is an open-label, multi-center, randomized, Phase 3 study designed to compare the
efficacy and safety of pegilodecakin in combination with FOLFOX versus FOLFOX alone in
participants with metastatic adenocarcinoma of the pancreas who have progressed on one prior
gemcitabine containing regimen.

Inclusion Criteria:

1. The presence of metastatic pancreatic adenocarcinoma

2. Measurable disease per RECIST v.1.1

3. Participant must have documented tumor progression during or following a gemcitabine
containing regimen to treat metastatic disease as established by CT or MRI scan

4. Eastern Cooperative Oncology Group Performance Status of 0 - 1

5. Participant must have completed prior chemotherapy at least 2 weeks (washout period)
prior to randomization and recovered from toxicity to Grade 1 or baseline

6. Participants must not have received previous radiation therapy or investigational
therapy for the treatment of advanced metastatic disease.

7. Participants having received cytotoxic doses of gemcitabine or any other chemotherapy
in the adjuvant setting are not eligible for this study

8. No peripheral neuropathy

9. No known history of dihydropyrimidine dehydrogenase deficiency

Exclusion Criteria:

1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma
(i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or
cystadenocarcinoma

2. Participant on Coumadin and not willing to change to LMWH or oral Factor II or Xa
inhibitor with half-life of less than 24 hours.

3. Participant has received prior treatment with pegilodecakin or
fluoropyrimidine/platinum containing regimen

4. Participants who were intolerant of a gemcitabine containing regimen.

5. History of positivity for human immunodeficiency virus

6. Chronic active or active viral hepatitis A, B, or C infection

7. Clinically significant bleeding within two weeks prior to randomization (e.g.,
gastrointestinal (GI) bleeding, intracranial hemorrhage)

8. Pregnant or lactating women

9. Participants with a history of immune-mediated neurological disorders such as multiple
sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders

10. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2- weeks

11. Major surgery, defined as any surgical procedure that involves general anesthesia and
a significant incision (i.e., larger than what is required for placement of central
venous access, percutaneous feeding tube, or biopsy),within 28 days prior to
randomization or anticipated surgery during the study period

12. Prior history of receiving immune modulators including, but not limited to,
anti-CTLA4, anti-PD1, anti-PD-L1
We found this trial at
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Fullerton, California 92835
Principal Investigator: David J Park
Phone: 321-843-8370
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3181 Southwest Sam Jackson Park Road
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503 494-8311
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220 S Palisade Dr # 204
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Arlington Heights, Illinois 60005
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Athens, Georgia 30607
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Austin, Texas 78705
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Bakersfield, California 93309
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
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Blue Island, Illinois 60406
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Boca Raton, Florida 33486
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Boston, Massachusetts 02215
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Caldwell, Idaho 83605
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4875 Higbee Ave NW
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330-492-3345
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Chattanooga, Tennessee 37401
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
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Dallas, Texas 75246
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2300 N Edward St
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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757 Westwood Plaza
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529 S Jackson St
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3800 Reservoir Rd NW
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