Advanced Metastatic Pancreatic Cancer MedDRA version: 21.1 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 100000004864
Conditions
Interventions
LY3500518
Other descriptive name: PEGylated recombinant human interleukin 10
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Trade Name: Oxaliplat
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The presence of metastatic pancreatic adenocarcinoma plus 1 of the following: a. Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR b. Pathologist confirmed histological/cytological diagnosis of adenocarcinoma consistent with pancreas origin in conjunction with either: i. The presence of a mass in the pancreas, OR ii. A history of pancreatic adenocarcinoma. 2. Measureable disease per RECIST v.1.1 3. Patient must have documented tumor progression during or following a gemcitabine containing regimen for the treatment of metastatic disease. Diagnosis of progression (by computed tomography (CT) or magnetic resonance imaging (MRI) or clinical progression) must be within 28 days prior to Randomization. 4. Only one prior gemcitabine containing therapy and no other prior therapies for metastatic disease. 5. Male or non-pregnant, non-lactating female, = 18 years or age. a. If a female patient is of child-bearing potential, as evidenced by menstrual periods, she must have a negative serum pregnancy test (ß-hCG) documented prior to the first administration of study drugs. b. If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator during the period of administration of study drugs. In addition, male and female patients must utilize contraception after the end of the treatment as recommended in the individual drugs comprising FOLFOX product’s Summary of Product Characteristics or Prescribing Information provided in the study manual and the Clinical Trial Facilitation Group. 6. Provide signed written informed consent. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1. 8. Patient must have completed prior chemotherapy and any investigational therapy at least 2 weeks (washout period) prior to randomization and recovered from toxicity to Grade 1 or baseline. 9. Willingness and ability to comply with study requirements. 10. Patient has adequate organ function by the following laboratory assessments at baseline (obtained =21 days prior to randomization): Hematologic * Platelets =100×109/L * Hemoglobin =9.0 g/dL * Absolute Neutrophil Count (ANC) =1.5×109/L * Patient has acceptable coagulation values obtained =21 days prior to randomization as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) =1.5 ULN (if on Coumadin, patient must be changed to LMW heparin (LMWH) or on Factor Xa anticoagulant with a half -life of less than 24 hours. 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 * Serum creatinine < 2.0 g/dL or calculated creatinine clearance = 60 mL/min for patients with serum creatinine levels above the institutional normal value. If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (e.g., using Modification of Diet in Renal Disease (MDRD) formula, (Levey, Coresh et al. 2006). For patients with a body mass inde
Exclusion criteria
Exclusion criteria: 1. Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma. 2. Patient has experienced a decrease in ECOG PS between screening visit and within 72 hours prior to randomization. 3. Patient on Coumadin and not willing to change to LMW H or oral Factor II or Xa inhibitor with half -life of less than 24 hours. 4. Patient has received prior treatment with AM0010 or a platinum containing regimen. 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 patient has been disease free for at least 3 years. Patients 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 patient inappropriate for the study. 7. Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics. 8. Patients who were intolerant to gemcitabine containing regimens (unable to receive at least 8 weeks of treatment) are not eligible. 9. Known history of positivity (regardless of immune status) for human immunodeficiency virus (HIV). 10. Known history of chronic active or active viral hepatitis A, B, or C infection 11. Clinically significant bleeding within two weeks prior to randomization (e.g., gastrointestinal (GI) bleeding, intracranial hemorrhage). 12. Pregnant or lactating women. 13. Patients with a history of immune mediated neurological disorders such as multiple sclerosis, Guillain-Barré, or inflammatory CNS/PNS disorders. 14. Myocardial infarction within the last 6 months prior to randomization, symptomatic congestive heart failure (New York Heart Association Classification > Class II, (Appendix E), unstable angina, or unstable cardiac arrhythmia requiring medication. 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. Peripheral neuropathy (> Grade 1) 19. Known history of dihydropyrimidine dehydrogenase deficiency (DPD). 20. Patients with abnormal EKG at baseline (QT or QTc interval > 450 msec for males; QT or QTc interval > 470 msec for females) will be excluded from this study. 21. Prior history of previous radiation therapy or surgery for the treatment of pancreatic cancer (e.g. Whipple or pancreatectomy, etc.). Prior history of receiving gemcitabine or any other chemotherapy in the adjuvant setting.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer as measured by OS.;Secondary Objective: To compare the efficacy of AM0010 in combination with FOLFOX versus FOLFOX alone in patients with metastatic pancreatic cancer as measured by: - PFS - ORR, DCR, and DoR by RECIST v.1.1 - 1-year overall survival rate To compare the safety and tolerability of AM0010 in combination with FOLFOX versus FOLFOX alone.;Primary end point(s): The primary endpoint of this study is OS is defined as the time from date of randomization to death. Patients who are no longer on study treatments should be followed for survival. A patient who is alive will be censored at the date last known to be alive.;Timepoint(s) of evaluation of this end point: Throughout entire study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints of the study include: • PFS is defined as the time from date of randomization to the earlier of first documentation of definitive disease progression or death due to any cause • ORR is defined as the proportion of patients who achieve a CR or PR as assessed by RECIST v.1.1;Timepoint(s) of evaluation of this end point: Throughout entire study duration | — |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Republic of, Poland, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed