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

Purpose

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.

Condition

  • Metastatic Pancreatic Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Olaratumab + Nab-paclitaxel + Gemcitabine (Dose Escalation)
(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given intravenously (IV).
  • Drug: Olaratumab
    Administered IV
    Other names:
    • LY3012207
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
Experimental
Olaratumab + Nab-paclitaxel + Gemcitabine (Cohort Expansion)
(Open Label) Olaratumab, nab-paclitaxel and gemcitabine given IV.
  • Drug: Olaratumab
    Administered IV
    Other names:
    • LY3012207
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
Experimental
Olaratumab + Nab-paclitaxel + Gemcitabine (Treatment)
(Double Blind) Olaratumab, nab-paclitaxel and gemcitabine given IV.
  • Drug: Olaratumab
    Administered IV
    Other names:
    • LY3012207
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
Placebo Comparator
Placebo + Nab-paclitaxel + Gemcitabine
(Double Blind) Placebo, nab-paclitaxel and gemcitabine given IV.
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
  • Drug: Placebo
    Administered IV

Recruiting Locations

Univ of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
210-450-1015

More Details

NCT ID
NCT03086369
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com