Trial Title:
Ampligen Compared to No Treatment Following FOLFIRINOX in Subjects With Locally Advanced Pancreatic Adenocarcinoma
NCT ID:
NCT05494697
Condition:
Pancreatic Cancer
Conditions: Official terms:
Adenocarcinoma
poly(I).poly(c12,U)
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Rintatolimod
Description:
Rintatolimod (poly I : poly C12U)
Arm group label:
Ampligen / rintatolimod
Other name:
Ampligen
Other name:
poly I : poly C12U
Summary:
The purpose of this study is to assess the safety and efficacy of Ampligen in patients
with locally advanced pancreatic adenocarcinoma
Detailed description:
This is a Phase 2, randomized, open-label controlled study to evaluate the efficacy and
safety of Ampligen treatment compared to a control group / no treatment following
FOLFIRINOX treatment in subjects with locally advanced pancreatic adenocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically:
Unresectable pancreatic cancer; locally advanced pancreatic cancer.
2. Measurable disease per RECIST v.1.1.
3. Completion of at least four (4) months of first line FOLFIRINOX treatment and no
disease progression per RECIST v.1.1 as confirmed by Computed Tomography (CT) or
Magnetic Resonance Imaging (MRI) scan 4 to 6 weeks after last FOLFIRINOX treatment.
4. Male or non-pregnant, non-lactating female, ≥18 years or age.
5. Negative pregnancy test for female subjects. Women of child-bearing potential
(WOCBP) and Women not of child-bearing potential are eligible to participate. Both
women of child-bearing potential and women of non-child-bearing potential should use
an approved method of birth control and agrees to continue to use this method for
the duration of the study and for 90 days after last treatment.
Acceptable methods of contraception include abstinence, female subject/partner's use
of hormonal contraceptive (oral, implanted, or injected) in conjunction with a
barrier method (WOCBP only), female subject/partner's use of an intrauterine device
(IUD), or if the female subject/partner is surgically sterile or two years
post-menopausal. All male subjects/partners must agree to use a condom consistently
and correctly for the duration of the study and for 90 days after last treatment. In
addition, subjects may not donate sperm for the duration of the study and for 90
days after the last treatment.
Females who are less than two (2) years post-menopausal, those with tubal ligations
and those using contraception must have a negative serum pregnancy test at baseline
within the one (1) week prior to the first study medication infusion. Every six
weeks, and at study termination a pregnancy test should be performed, either serum
or urine stick test. However, if the urine result is positive, a serum pregnancy
test will be performed.
Any pregnancy that occurs while taking Ampligen® should be recorded using a
Pregnancy Report Form and reported immediately to AIM ImmunoTech, Inc.
6. Provide signed written informed consent and willingness, ability to comply with
study requirements.
7. Minimum weight of 40kg at baseline.
8. Karnofsky Performance Status of 80 or higher at baseline.
9. Subject must have a projected life expectancy of ≥ 3 months in the opinion of the
Investigator.
10. Subject has adequate organ function by the following laboratory assessments at
baseline (obtained ≤ 28 days prior to Visit 2/First Treatment:
Hematologic:
Platelets ≥ 100×109/L Hemoglobin ≥ 9.0 g/dL Absolute Neutrophil Count (ANC) ≥ 1.5×109/L
Absolute lymphocyte count ≥ 3 x 109/L
Hepatic:
AST/ALT ≤ 3×ULN (if liver metastases are present, ≤ 5×ULN) Alkaline phosphatase ≤ 2.0×ULN
(if liver metastases are present, ≤ 5×ULN) Total bilirubin ≤ 1.5×ULN Albumin ≥ 3.0 g/dL
Renal:
Creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula.
Coagulation:
PT-INR and APTT within normal limits
Exclusion Criteria:
1. Diagnosis of islet neoplasm acinar cell carcinoma, non-adenocarcinoma (i.e.,
lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or
cystadenocarcinoma.
2. Subjects who have surgically resectable locally advanced pancreatic adenocarcinoma
following treatment with FOLFIRINOX.
3. Subject has received prior treatment with Ampligen®.
4. Therapy with investigational drugs within 6 weeks of beginning study medication.
5. History of prior malignancy, except for adequately treated in situ cancer, basal
cell, squamous cell skin cancer, or other cancers (e.g., breast, prostate) for which
the subject has been disease-free for at least 3 years. Subjects with prior cancer
that is adequately controlled per the judgement of the Investigator will not be
excluded from the study.
6. Any serious medical condition, laboratory abnormality, psychiatric illness, or
comorbidity that, in the judgment of the Investigator, would make the subject
inappropriate for the study.
7. Serious systemic fungal, bacterial, viral, or other infection that is not controlled
or requires intravenous (IV) treatment for infection(s).
8. Known history of positivity (regardless of immune status) for human immunodeficiency
virus (HIV).
9. Known history of, chronic active, or active viral hepatitis A, B, or C infection
10. Clinically significant bleeding within 2 weeks prior to Randomization (e.g.,
gastrointestinal [GI] bleeding, intracranial hemorrhage).
11. Pregnant or lactating women.
12. Myocardial infarction within the last 6 months prior to Randomization, symptomatic
congestive heart failure (New York Heart Association Classification > Class II),
unstable angina, or unstable cardiac arrhythmia requiring medication.
13. Subjects with abnormal electrocardiogram (ECG) at baseline QTc interval >470 ms
(calculated using both the Bazett's and Fridericia's corrections).
14. Subjects with positive germline BRCA (gBRCA) mutations.
15. Clinically significant ascites defined as requiring ≥ 1 paracentesis every 2 weeks.
16. Major surgery, defined as any surgical procedure that involves general anesthesia
and a significant incision (i.e., larger than what is required for placement of
central venous access, percutaneous feeding tube, or biopsy), within 28 days prior
to Randomization or anticipated surgery during the study period.
17. Prior history of receiving immune checkpoint inhibitors (anti-CTLA4, anti-PD1,
anti-PD- L1).
18. Inability to return for scheduled treatment and assessments.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica E Delaney, BSN
Phone:
402-559-8711
Email:
jessdelaney@unmc.edu
Investigator:
Last name:
Kelsey Klute, MD
Email:
Principal Investigator
Facility:
Name:
Gabrail Cancer Center Research
Address:
City:
Canton
Zip:
44718
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carrie Smith
Phone:
330-492-3345
Phone ext:
208
Email:
csmith@gabrailcancercenter.com
Investigator:
Last name:
Nashat Y. Gabail, MD
Email:
Principal Investigator
Facility:
Name:
Virginia Mason Medical Center
Address:
City:
Seattle
Zip:
98101
Country:
United States
Status:
Recruiting
Contact:
Last name:
Colette Treperinas
Phone:
206-287-6286
Email:
colette.treperinas@vmfh.org
Investigator:
Last name:
Vincent Picozzi, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
April 2028
Lead sponsor:
Agency:
AIM ImmunoTech Inc.
Agency class:
Industry
Collaborator:
Agency:
Amarex Clinical Research
Agency class:
Other
Source:
AIM ImmunoTech Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05494697