A study of nab-paclitaxel and gemcitabine with or without olaratumab for treatment of pancreatic cancer that has spread to other parts of the body.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 184

Inclusion Criteria

[1] have histological or cytological diagnosis of adenocarcinoma of the exocrine
pancreas that is metastatic (Stage IV) and not amenable to resection with
curative intent and be patients for whom nab-paclitaxel-gemcitabine therapy is
considered by the investigator to be an appropriate treatment. Patients with
previous radical surgery for pancreatic cancer are eligible after progression is
documented.
[2] if present, clinically significant or symptomatic amounts of ascites should be
drained prior to Day 1
[3] have sufficient available material from an archived formalin-fixed paraffinembedded
(FFPE) tumor tissue for biomarker-related studies. If such tissue is
not available, a newly obtained core or excisional biopsy of a tumor lesion
must be performed in the Phase 2 portion of the study.
[4] The patient has measurable or nonmeasurable but evaluable disease as defined
by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1,
Eisenhauer et al. 2009). Tumors within a previously irradiated field will be
designated as nontarget” lesions unless progression is documented or a
biopsy is obtained to confirm persistence at least 90 days following
completion of radiotherapy.
[5] have had no prior systemic treatment for metastatic disease. Prior adjuvant or
neo-adjuvant chemotherapy or radiochemotherapy use of gemcitabine
monotherapy is allowed if completed = 3 months prior to enrollment. Prior
treatment with 5-Fluorouracil (5-FU) administered as a radiation sensitizer in
the adjuvant setting is allowed, if completed =3 months prior to enrollment
and no lingering toxicities are present.
[6] prior radiation therapy for treatment of cancer is allowed to <25% of the bone
marrow (Cristy and Eckerman 1987). Patients must have recovered from the
acute toxic effects of their treatment prior to study enrollment. Prior
radiotherapy must be completed =3 months prior to study entry.
[7] have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology
Group (ECOG) scale (Oken et al. 1982)
[8] have discontinued all previous treatments for cancer and recovered from the
acute effects of therapy. Patients must have discontinued from previous
treatments (radiotherapy/
[9] have adequate organ function
[10] are at least 18 years old at the time of screening/randomization
[11] If male, the patient is sterile (including vasectomy) or agrees to use an
effective method of birth control. Refer to Appendix 1 for definitions of
effective method
[12] If female:
o is not of childbearing potential due to surgical sterilization confirmed by
medical history (at least 6 weeks post-surgical bilateral oophorectomy with or
without hysterectomy or tubal ligation) or menopause
o is of childbearing potential, has a negative serum or urine pregnancy test
within 72 hours prior to the first dose of study treatment, agrees to use a
highly effective method of birth control during the study and for up to
120 days following the last dose of the study treatment, and is not
breastfeeding. If the urine test is positive or cannot be confirmed as negative,
a serum pregnancy test will be required. Refer to Appendix 1 for definitions
of effective method of contraception and highly effective method of
contraception.
[13] have given written informed consent/assent prior to any study-specific
procedures
[14] has a life expectancy of at least 3 months in the opinion of the investigators
Are the trial subjects under 18? no
Number of

Exclusion Criteria

[15] have received first line treatment for metastatic pancreatic cancer.
[16] have received prior treatment with FOLFOX or FOLFIRINOX.
[17] have a serious concomitant systemic disorder (for example, active infection
including human immunodeficiency virus, or cardiac disease) or other
condition that, in the opinion of the investigator, would compromise the
patient’s ability to adhere to the protocol
[18] have known central nervous system (CNS) malignancy or metastasis
(screening not required)
[19] have current hematologic malignancies, acute or chronic leukemia
[20] have participated within the last 30 days in a clinical trial involving an
investigational product. If the previous investigational product has a long
half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
[21] are women with a positive pregnancy test or who are lactating
[22] have endocrine pancreatic tumors or ampullary cancer
[23] are currently enrolled in a clinical trial involving an investigational product or
any other type of medical research judged not to be scientifically or medically
compatible with this study
[24] have a history of any other cancer (except non-melanoma skin cancer or
carcinoma in-situ), unless in complete remission and off all therapy for that
disease for a minimum of 1 year
[25] have known allergy to nab-paclitaxel, gemcitabine, or any ingredient of
olaratumab, nab-paclitaxel, or gemcitabine formulations

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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ELI LILLY & COMPANY, LILLY CORPORATE CENTER

Updated 8/17/2021