Regorafenib Plus Gemcitabine In Metastatic Pancreatic Cancer

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-03-04	Results First Submitted 2019-03-22	Last Update Submitted that met QC Criteria 2023-10-16
First Submitted that Met QC Criteria 2015-03-04	Results First Submitted that Met QC Criteria 2019-04-18	Last Update Posted (ACTUAL) 2023-10-23
First Posted (ACTUAL) 2015-03-09	Results First Posted 2019-05-10	Last Verified 2023-10

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (regorafenib, gemcitabine hydrochloride) 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 Given PO DRUG: Gemcitabine Hydrochloride Given IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (regorafenib, gemcitabine hydrochloride)

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

Given PO

DRUG: Gemcitabine Hydrochloride

Given IV

Primary Outcome Measures	Measure Description	Time Frame
Progression-free Survival	Time-to-event data will be summarized using the Kaplan-Meier method.	Up to 1 year from enrollment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
Serum creatinine =< 1.5 x the ULN
International normalized ratio (INR)/partial thromboplastin time (PTT) 1.5 x ULN; (subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care)
Platelet count >= 100000/mm^3, hemoglobin (Hb) ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm^3; blood transfusion to meet the inclusion criteria will not be allowed
Women of childbearing potential must have a negative serum 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
Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Subject must be able to swallow and retain oral medication

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
Any infection requiring ongoing intravenous antibiotics for management
Symptomatic metastatic brain or meningeal tumors; treated and stable, asymptomatic brain metastases, as long as treatment was greater than 4 weeks prior to informed consent, are allowed
Presence of a non-healing wound, non-healing ulcer, or bone fracture
Renal failure requiring hemo-or peritoneal dialysis
Dehydration grade >= 1 NCI-CTCAE v4.0
Patients with seizure disorder requiring medication
Persistent proteinuria >= grade 3 NCI-CTCAE v4.0 (> 3.5 g/24 hrs, measured by urine protein:creatinine ratio on a random urine sample)
Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
Pleural effusion or ascites that causes respiratory compromise (>= NCI-CTCAE version 4.0 grade 2 dyspnea)
History of organ allograft (including corneal transplant)
Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial
Any malabsorption condition
Women who are pregnant or breast-feeding
Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results

Collaborators and Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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Resources

Patients

Caregivers

Clinical Trial Record