A Study of Regorafenib in Advanced Pancreatic Cancer Patients

NCT02080260 | Completed Phase 2 Results DMC

• 1 other identifier: LCI-GI-PAN-REG-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects

  16-week progression free survival was determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 16 weeks after treatment start, with progression defined radiographically using RECIST v1.1 or clinically based upon investigator assessment.

  16 weeks after enrollment

Secondary Outcomes (4)

• Progression Free Survival

  From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.

• Overall Survival

  From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.

• Overall Response

  From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)

• Disease Control

  From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)

Study Arms (1)

Single Arm

EXPERIMENTAL

Oral Regorafenib

Drug: regorafenib

Interventions

regorafenib DRUG

Single agent drug therapy with regorafenib

Also known as: Stivarga

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Bayer: collaborator

Study Sites (12)

Levine Cancer Institute-Albemarle

Albemarle, North Carolina, 28001, United States

Location

Levine Cancer Institute-South Tryon

Charlotte, North Carolina, 28203, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Levine Cancer Institute - Pineville

Charlotte, North Carolina, 28210, United States

Location

Levine Cancer Institute - Southpark

Charlotte, North Carolina, 28211, United States

Location

Levine Cancer Institute - Mallard Creek

Charlotte, North Carolina, 28262, United States

Location

Levine Cancer Institute - University

Charlotte, North Carolina, 28262, United States

Location

Levine Cancer Institute - Ballantyne

Charlotte, North Carolina, 28277, United States

Location

Levine Cancer Institute - Concord

Concord, North Carolina, 28025, United States

Location

Levine Cancer Institute-Monroe

Monroe, North Carolina, 28112, United States

Location

Levine Cancer Institute - Cleveland

Shelby, North Carolina, 28150, United States

Location

Low Country Hematology Oncology

Charleston, South Carolina, 29406, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chair of Biostatistics Department
• Organization: Levine Cancer Institute

james.symanowski@atriumhealth.org

9804422371

Study Officials

• John S Salmon, MD

  Atrium Health Levine Cancer Institute

  PRINCIPAL INVESTIGATOR

• Edward Kim, MD

  Atrium Health Levine Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2014
• First Posted: March 6, 2014
• Study Start: June 6, 2014
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: April 21, 2022
• Results First Posted: July 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)