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

NCT02021422 | Completed Phase 1 DMC

• 1 other identifier: 013-018
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The study's overall objectives are to evaluate the safety of anakinra in combination with standard chemotherapy regimens in patients with pancreatic ductal adenocarinoma, as well as to collect preliminary immune modulation and clinical activity information, overall survival, and serious adverse events related to the study drug.

Conditions

Pancreas Cancer

Keywords

metastatic pancreatic ductal adenocarcinoma (PDAC); pancreatic cancer; pancreas cancer; pancreatic adenocarcinoma; metastatic pancreas cancer; metastatic pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Participants with SAEs and AEs.

  Test the safety of Anakinra in combination with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) as evidenced by the Number of Participants with serious adverse events (SAEs) and adverse events (AEs).

  6 months

Secondary Outcomes (4)

• Overall Survival

  6 months

• Adverse events associated with injection site reactions and the incidence of infections

  6 Months

• Data Collection: tumor measurements by CT scans

  6 months

• Gather preliminary information on the immune modulation and clinical activity of this therapy

  6 month

Study Arms (1)

Anakinra with Modified Folfirinox

OTHER

8-weeks of anakinra and modified FOLFIRINOX regimen (refer to Appendix 9 for regimen) as follows Kineret (anakinra) Dosage Route Administration 100 mg SC Every Other Day Modified FOLFIRINOX Drug Dose Administration Oxaliplatin 85 mg/m2 2-4 hours Irinotecan 180 mg/m2 90 minutes fluorouracil 2400 mg/m2 48 hours

Drug: anakinra; Drug: Oxaliplatin; Drug: Irinotecan; Drug: fluorouracil

Interventions

anakinra DRUG

Dosage Route Administration 100 mg SC Every Other Day

Also known as: Kineret

Anakinra with Modified Folfirinox

Oxaliplatin DRUG

Oxaliplatin 85 mg/m2 2-4 hours

Anakinra with Modified Folfirinox

Irinotecan DRUG

Irinotecan 180 mg/m2 90 minutes

Also known as: Camptosar

Anakinra with Modified Folfirinox

fluorouracil DRUG

fluorouracil 2400 mg/m2 48 hours

Also known as: 5 FU

Anakinra with Modified Folfirinox

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Interleukin 1 Receptor Antagonist Protein; Oxaliplatin; Irinotecan; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Carlos Becerra, MD

  Baylor Sammons Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2021
• Last Updated: February 18, 2026

Record last verified: 2025-11

Locations

US (1)