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: 186

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 (other than nab-paclitaxel) 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.
[7] have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology
Group (ECOG) scale (Oken et al. 1982)
[8] Patients must have discontinued from previous treatments for cancer (radiotherapy/major surgery, excluding biopsy) 4 weeks prior to study
treatment.[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 definitionsof effective method of contraception and highly effective method of contraception.
[13] have given written informed consent/assent prior to any studyspecific 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 subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

[15] have received first line treatment for metastatic pancreatic cancer.
[16] have received prior treatment with nab-paclitaxel
[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 known additional malignancy that is progressing or riquired active treatments within the past 1 year Note: Participants with basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma,cervical cancer in situ)
[25] have known allergy to nab-paclitaxel, gemcitabine, or Olaratumab (levels of IgE antibodies against a-gal that are above the upper limit of normal) 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

Related Trials