A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Metastatic Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT03086369
- Run by
- Eli Lilly and Company
- People needed
- 184
- Starts
- 2017-06-22
- Expected to finish
- 2021-06-17
- Last updated by the study team
- 2022-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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