Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cornerstone Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed metastatic stage IV adenocarcinoma of the pancreas
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
Male and female patients 18 - 75 years of age
Measurable disease determined using guidelines of Response Evaluation Criteria In Solid Tumors (RECIST version 1.1)
Recurrrence or progression while on FFX therapy.
Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must agree to use acceptable highly effective contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive(s), intrauterine hormone releasing system (IUS), bilateral tubal occlusion or vasectomized partner) during and for 6 months after last study dose and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
Males with female partners (of childbearing potential) and female partners (of childbearing potential) with male partners must agree to use double barrier contraceptive measure (a combination of male condom with either cap, diaphragm or sponge with spermicide) in addition to oral contraception, or avoidance of intercourse during the study and for 6 months after last study dose is received
At least 4 weeks from major surgery with resolution of any sequela to date of enrollment
Laboratory values ≤2 weeks during screening must be:
Adequate hematologic values
* Platelet count ≥100,000 cells/mm3 or ≥100 bil/L;
* Absolute neutrophil count \[ANC\] ≥1,500 cells/mm3 or ≥1.5 bil/L;
* Hemoglobin \>9 g/dL or \>90 g/L
Adequate hepatic function
* Aspartate aminotransferase \[AST/SGOT\] ≤3x upper normal limit \[UNL\] (≤5xUNL if liver metastasis present)
* Bilirubin (≤1.5x UNL); bilirubin ≤ 2.5 x ULN for subjects with Gilbert's syndrome
Adequate renal function
* Serum creatinine clearance CLcr \> 30 mL/min). (Cockcroft-Gault Formula should be used for CrCl calculation)
Adequate coagulation function
* International Normalized Ratio or INR must be \<1.5 unless on anticoagulants
No evidence of active infection and no serious infection within the past 30 days. Patient must have completed antibiotic course.
Mentally competent, ability to understand and willingness to sign the informed consent form and follow protocol requirements
You may not be if
Endocrine or acinar pancreatic carcinoma
Known cerebral metastasis, central nervous system (CNS), or epidural tumor
Patients with hypersensitivity to devimistat, FFX treatment or any of their excipients
Patients receiving any other investigational systemic agent for any indication within the past 2 weeks prior to initiation of devimistat treatment
Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g., Hemophilia A)
Female patients who are pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 6 months after the last dose of study treatment
Female patients of childbearing potential with a positive pregnancy test assessed by a serum pregnancy test at screening
Male patients unwilling to abstain from donating sperm during treatment and for 6 months after completion of study treatment
Active heart disease including but not limited to symptomatic congestive heart failure (NYHA class 3 or 4), symptomatic coronary artery disease, symptomatic angina pectoris, or symptomatic myocardial infarction
Patients with a history of myocardial infarction that is \<3 months prior to registration
Prior malignancy except for the following: adequately treated basal or squamous cell skin cancer, in situ cancer, localized prostate cancer (Gleason score \<8), or adequately treated cancer from which the patient has been disease-free for at least 3 years prior to screening
Unwilling or unable to avoid the concomitant use of strong CYP3A4 inducers or inhibitors during treatment with irinotecan (Listed in the APPENDIX II: CYP3A4 Inducers or Inhibitors)
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 470 milliseconds (ms) (CTCAE grade 1) using Fridericia's QT correction formula (i.e. QTcF)
A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
The use of concomitant medications except anti-emetics that prolong the QT/QTc intervals.
