Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer

NCT02383433 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: CASE5214NCI-2015-00146P30CA043703
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well regorafenib and gemcitabine hydrochloride work as second-line therapy (treatment given when initial treatment doesn't work) in treating patients with pancreatic cancer that has spread to other parts of the body. Regorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving regorafenib together with gemcitabine hydrochloride may kill more tumor cells.

Conditions

Metastatic Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Time-to-event data will be summarized using the Kaplan-Meier method.

  Up to 1 year from enrollment

Study Arms (1)

Treatment (regorafenib, gemcitabine hydrochloride)

EXPERIMENTAL

Patients receive regorafenib PO QD on days 1-21 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Regorafenib; Drug: Gemcitabine Hydrochloride

Interventions

Regorafenib DRUG

Given PO

Also known as: BAY 73-4506, multikinase inhibitor BAY 73-4506, Stivarga

Treatment (regorafenib, gemcitabine hydrochloride)

Gemcitabine Hydrochloride DRUG

Given IV

Also known as: dFdC, dFdCyd

Treatment (regorafenib, gemcitabine hydrochloride)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant)
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \> 20 mm with conventional techniques or as \> 10 mm with spiral computed tomography (CT) scan
• Prior Therapies: Patients must have received at least one prior systemic chemotherapy regimen for metastatic pancreatic cancer. They should have experienced disease progression or intolerable toxicity from that regimen.
• Patients who have received prior non-gemcitabine-based systemic chemotherapy for metastatic disease at any time 4 weeks prior to enrollment, or those who are beyond 12 months of exposure to gemcitabine-based chemotherapy regimen are allowed.
• Prior chemotherapy, radiation therapy, concurrent chemoradiation are allowed if used for treatment of non-metastatic disease.
• Any chemotherapy must have been completed 4 weeks prior to enrollment
• Any radiotherapy must have been completed 2 weeks prior to enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy of at least 12 weeks (3 months)
• Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure
• All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v)4.0 grade 1 or less at the time of signing the informed consent form (ICF)
• Total bilirubin =\< 1.5 x the upper limits of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer)
• Alkaline phosphatase limit =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer)
• Lipase =\< 1.5 x the ULN

You may not qualify if:

• Chemotherapy within 4 weeks prior to entering the study, radiotherapy within 2 weeks prior to entering the study or failure to recover from adverse events to grade 1 or less due to agents administered more than 4 weeks earlier
• Use of any other investigational agents
• Previous assignment to treatment during this study; subjects permanently withdrawn from study participation will not be allowed to re-enter study
• Uncontrolled hypertension (systolic pressure \> 140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v4.0\] on repeated measurement) despite optimal medical management
• Active or clinically significant cardiac disease including:
• Congestive heart failure - New York Heart Association (NYHA) \> class II
• Active coronary artery disease
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
• Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization
• Evidence or history of bleeding diathesis or coagulopathy
• Any hemorrhage or bleeding event \>= NCI CTCAE grade 3 within 4 weeks prior to start of study medication
• Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of informed consent
• Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from pancreatic cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form)
• Patients with phaeochromocytoma
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

regorafenib; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Data was not collected, study terminated early due to low accrual.

Results Point of Contact

• Title: Davendra Sohal
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

sohald@ccf.org

+1 216-444-8258

Study Officials

• Davendra Sohal, MD, MPH

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Jennifer Eads, MD

  Case Comprehensive Cancer Center

  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 4, 2015
• First Posted: March 9, 2015
• Study Start: June 14, 2016
• Primary Completion: September 1, 2017
• Study Completion: May 10, 2018
• Last Updated: October 23, 2023
• Results First Posted: May 10, 2019

Record last verified: 2023-10

Locations

US (1)