Clinical trial NCT02080260 (phase 2, status: completed)
Conditions: pancreatic cancer
ICD codes: C25.3
Drugs: regorafenib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Adenocarcinoma of the exocrine pancreas with metastatic disease.

          -  The site of the primary tumor confirmed to have been within the pancreas.

          -  Progression on at least one prior line of chemotherapy for locally-advanced or
             metastatic pancreatic cancer.

          -  Progression while on treatment with a gemcitabine regimen for advanced pancreatic
             cancer, or within 12 months of treatment with gemcitabine as part of adjuvant therapy.

          -  Measurable disease on axial imaging.

          -  Age greater than or equal to 18 years.

          -  Life expectancy of at least 8 weeks.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. Enrollment of
             patients with PS = 2 will be capped at 7 patients.

          -  Subjects must be able to understand and be willing to sign the written informed
             consent form.

          -  Acute toxic effects except alopecia of any prior treatment must have resolved to
             National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
             v4.0 Grade 1 or less.

          -  Adequate bone marrow, renal, and liver function.

          -  Warfarin or heparin will be allowed provided that there is no prior evidence of
             underlying coagulation abnormality.

          -  Women of childbearing potential must have a negative pregnancy test performed within 7
             days prior to the start of study drug. Post-menopausal women (defined as no menses for
             at least 1 year) and surgically sterilized women are not required to undergo a
             pregnancy test.

          -  Patients (men and women) of childbearing potential must agree to use adequate
             contraception

          -  Patient must be able to swallow and retain oral medication.

        Exclusion Criteria:

          -  Previous assignment to treatment during this study.

          -  Uncontrolled hypertension.

          -  Active clinically significant cardiac disease.

          -  Cerebrovascular arterial event within 6 months.

          -  Evidence or history of bleeding diathesis or coagulopathy.

          -  Any bleeding event greater than or equal to NCI CTCAE Grade 3 within 4 weeks.

          -  New venous thrombotic or embolic events, such as deep vein thrombosis or pulmonary
             embolism within 3 months.

          -  Previously untreated or concurrent cancer that is distinct in primary site or
             histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial
             bladder tumor. Patients surviving a cancer that was curatively treated and without
             evidence of disease for more than 3 years are allowed.

          -  Patients with pheochromocytoma.

          -  Known history of HIV infection or current chronic or active hepatitis B or C,
             requiring antiviral medication.

          -  Ongoing infection greater than or equal to Grade 2 NCI-CTCAE v4.0.

          -  Symptomatic metastatic brain or meningeal tumors.

          -  Presence of a non-healing wound, non-healing ulcer, or bone fracture.

          -  Renal failure requiring dialysis.

          -  Dehydration Grade greater than or equal to 1 NCI-CTCAE v4.0.

          -  Patients with seizure disorder requiring medication.

          -  Persistent proteinuria greater than or equal to Grade 3 NCI-CTCAE v4.0.

          -  Symptomatic interstitial lung disease.

          -  Pleural effusion or ascites that cause respiratory compromise.

          -  History of organ allograft except corneal transplant.

          -  Known or suspected allergy or hypersensitivity to the study drugs.

          -  Any severe, uncontrolled malabsorption condition.

          -  Women who are pregnant or breast-feeding.

          -  Substance abuse, medical, psychological or social conditions that may interfere with
             the subject's participation in the study.

          -  Concurrent anti-cancer therapy other than study treatment (regorafenib).

          -  Prior use of regorafenib.

          -  Concurrent use of another investigational drug or device therapy (i.e., outside of
             study treatment) during, or within 4 weeks.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days.

          -  Prior radiation therapy or hepatic arterial therapy is permitted if more than 4 weeks
             have passed since completion and measurable disease outside of the treated area is
             present, or if progression since treatment has occurred.

          -  Use of St. John's Wort.