A Pilot, Prospective, Non-randomized Evaluation of the Safety of Anakinra Plus Standard Chemotherapy

Kineret (anakinra) is a FDA-approved drug indicated for rheumatoid arthritis. Anakinra is a
recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra).
Anakinra blocks the biologic activity of IL -1 by competitively inhibiting IL-1 binding to
the interleukin-1 type I receptor (IL-1RI), which is expressed in a wide variety of tissues
and organs. IL-1 production is induced in response to inflammatory stimuli and mediates
various physiologic effects including inflammatory and immunological responses.

This is a pilot, prospective, non-randomized, consecutive enrollment study that will enroll
up to 12 subjects who meet the study defined inclusion and exclusion criteria.

Subjects will undergo standard of care chemotherapy treatment/regimens (i.e., modified
FOLFIRINOX). Subjects will be dispensed a 2 weeks supply of anakinra the day they begin
chemotherapy. They will be instructed to begin self-administering the anakinra (study drug)
injections the day after their first dose of chemotherapy.

They will have a blood sample collected at baseline and 6 months follow up. If they have
surgery for their disease, they may have a tissue sample collected for later analysis.

Inclusion Criteria:

- 18 years of age or older

- Male or non-pregnant and non-lactating female

- Confirmed metastatic/inoperable metastatic pancreas cancer and/or
Histologically/cytologically confirmed metastatic adenocarcinoma of pancreas

- Patients' blood counts and blood chemistry levels at baseline must be not clinically
significant (NCS) as determined by the enrolling investigator.

- Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 2
(refer to Appendix 5):

- Signed study consent form

Exclusion Criteria:

- <18 years of age

- Pregnant or lactating female

- Patient has islet cell neoplasms

- Active secondary malignancies (2nd cancer not treated/present)

- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic
therapy

- Known infection with hepatitis B, hepatitis C, or cirrhosis

- Major surgery or vascular device placement (excluding ports for IV
medication/chemotherapy) within 2 weeks prior to Day 1 of treatment in study

- History of allergy or hypersensitivity to the study drugs

- Patient is enrolled in any concurrent-outside (outside Baylor University Medical
Center or Texas Oncology) clinical protocol or investigational trial

- Significant cardiac disease as defined as New York Heart Association (NYHA)
classification III or IV, uncontrolled CHF, or prior MI last 6-months

- Any prior gastrointestinal (GI) disease or history of prior pelvic or abdominal
radiation which in the opinion of the investigator may place the patient at increased
risk

- Peripheral sensory neuropathy ≥ to grade 2 at baseline

- Significant co-morbidities deemed by investigator as unsuitable for
participation/enrollment

- Study consent form not signed