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New treatment option for Pancreatic Adenocarcinoma
Official title Chemotherapy + Anakinra in Patients With Pancreatic Adenocarcinoma (PDAC)
ClinicalTrials.gov ID: NCT04926467
What this study is testing
What is Anakinra?
Anakinra is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for pancreatic adenocarcinoma.
Also referred to as Kineret.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Based on a central role of inflammation in pancreas cancer, the role of IL 1 in acute and chronic inflammation , the inhibitory effect of IL 1 alfa and beta by anakinra and preliminary experience with anakinra in combination with chemotherapy in metastasis (with FOLFIRINOX) and localized disease (with gemcitabine/abraxane/cisplatin), a phase 2 study with anakinra in combination with perioperative chemotherapy for patients with PDAC is being proposed.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:
- 18 years of age or older
- Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of...
- Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
- American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
You likely can't join if
- A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
- \<18 years of age
- History of organ transplant.
- Patients with islet cell neoplasms
- Patients with stage IV pancreatic carcinoma
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
See the full eligibility criteria
- A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:
- 18 years of age or older
- Histologically or Cytologically confirmed pancreatic ductal adenocarcinoma. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma.
- Resectable, locally advanced or potentially resectable pancreatic adenocarcinoma
- American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
- Patient has Eastern Cooperative Oncology Group( ECOG ) Performance Status 0 to 1
- Serum albumin ≥2.0 g/dL.
- Adequate hematologic function as defined by:
- Absolute neutrophil count (ANC) ≥1500/mm3;
- Platelets ≥70,000 x 10\^3/µl;
- Hemoglobin ≥9 g/dL (in the absence of red blood transfusion).
- Adequate liver function, as defined by:
- Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
- ALT (SGPT) and AST (SGOT) ≤2.5 x upper limit of normal (ULN).
- Adequate renal function, as defined by serum creatinine≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
- Women of child bearing potential and men must agree to use contraception throughout the study and for one month after the last anakinra administration.
- people must understand and sign the informed consent form
- Patients must be accessible for treatment and follow-up.
- A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:
- \<18 years of age
- History of organ transplant.
- Patients with islet cell neoplasms
- Patients with stage IV pancreatic carcinoma
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Known active infection with hepatitis B or hepatitis C
- Presence of clinically significant cirrhosis as determined by the investigator
- Known HIV positive status.
- Current, active immunosuppressive therapy such as cyclosporine, tacrolimus, etc.
- Major surgery or vascular device placement within 2 weeks prior to Day 1 of treatment in study
- Prior chemotherapy or radiation for pancreatic cancer
- History of allergy or hypersensitivity to the study drugs
- Patient is enrolled in any outside therapeutic clinical protocol or investigational trial with an investigational drug within 5 half-lives prior to Study ID assignment
- Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor
- Other malignancy within five years(except cutaneous, non-melanoma malignancies or cervical carcinoma in site), unless the probability of recurrence of the prior malignancy is \<5% as determined by the Principal...
- Significant cardiac disease (uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias) within the last six months.
- Other severe and/or uncontrolled medical conditions (e.g: prior gastrointestinal (GI) disease or history of prior pelvic or abdominal radiation) or other conditions deemed by investigator as unsuitable for...
- Peripheral sensory neuropathy \> or equal to grade 2 at baseline
- Abnormal liver function tests as follows:
- Total bilirubin of \> 2 x ULN
- AST or ALT \> 5x ULN
- Serum albumin ˂ 2.0 g/dL.
- Abnormal hematologic function as follows :
- Absolute neutrophil count (ANC) ˂ 1500/mm3;
- Platelets ˂ 70,000 x 10\^3/µl;
- Hemoglobin ˂ 9 g/dL (in the absence of red blood transfusion).
- Pregnant or nursing women
- No signed Informed consent form
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.