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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

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
Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine 		Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m^2) and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
  • Drug: Olaratumab
    Administered IV
    Other names:
    • LY3012207
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
Experimental
Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine 		Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
  • Drug: Olaratumab
    Administered IV
    Other names:
    • LY3012207
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
Experimental
Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine 		Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
  • Drug: Olaratumab
    Administered IV
    Other names:
    • LY3012207
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
Experimental
Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine 		Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
  • Drug: Olaratumab
    Administered IV
    Other names:
    • LY3012207
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
Placebo Comparator
Phase 2: Placebo + Nab-paclitaxel + Gemcitabine 		Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m^2 and gemcitabine 1000 mg/m^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.
  • Drug: Nab-paclitaxel
    Administered IV
  • Drug: Gemcitabine
    Administered IV
  • Drug: Placebo
    Administered IV

More Details

Status
Completed
Sponsor
Eli Lilly and Company

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.