A Study of Regorafenib in Advanced Pancreatic Cancer Patients

Completed · Phase 2

Conditions studied: Pancreatic Cancer

In brief

This study tests regorafenib as a single agent in the treatment of metastatic pancreatic cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis for these patients is particularly grim, no other standard treatment options exist, and novel approaches are desperately needed.

Key facts

Study ID

NCT02080260

Run by

Wake Forest University Health Sciences

People needed

20

Starts

2014-06-06

Expected to finish

2017-06-28

Last updated by the study team

2022-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Levine Cancer Institute-Albemarle — Albemarle, North Carolina, United States
• Levine Cancer Institute-South Tryon — Charlotte, North Carolina, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Levine Cancer Institute - Pineville — Charlotte, North Carolina, United States
• Levine Cancer Institute - Southpark — Charlotte, North Carolina, United States
• Levine Cancer Institute - Mallard Creek — Charlotte, North Carolina, United States
• Levine Cancer Institute - University — Charlotte, North Carolina, United States
• Levine Cancer Institute - Ballantyne — Charlotte, North Carolina, United States
• Levine Cancer Institute - Concord — Concord, North Carolina, United States
• Levine Cancer Institute-Monroe — Monroe, North Carolina, United States
• Levine Cancer Institute - Cleveland — Shelby, North Carolina, United States
• Low Country Hematology Oncology — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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