A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer

Status: Active

Description

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.

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.

Locations & Contacts

Arizona

Tucson
Banner University Medical Center - Tucson
Status: Active
Contact: Brandy Duncan
Phone: 520-626-9083
Email: BHD@email.arizona.edu

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Approved
Contact: Kyanne O'Bryant
Phone: 818-847-4722
Email: obryant@usc.edu

Connecticut

New Haven
Yale University
Status: Approved
Contact: Kamil Sadowski
Phone: 203-785-6661
Email: kamil.sadowski@yale.edu

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Name Not Available

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: In review
Name Not Available

New York

Buffalo
Roswell Park Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Temporarily closed to accrual
Name Not Available

South Carolina

Charleston
Medical University of South Carolina
Status: Temporarily closed to accrual
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: Temporarily closed to accrual
Name Not Available

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
Eli Lilly and Company

Trial IDs

Primary ID 15844
Secondary IDs NCI-2017-02144, 2016-001099-31, I5B-MC-JGDP
Clinicaltrials.gov ID NCT03086369