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Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02383433
Recruitment Status : Terminated
First Posted : March 9, 2015
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Adenocarcinoma
Interventions Drug: Regorafenib
Drug: Gemcitabine Hydrochloride
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Regorafenib, Gemcitabine Hydrochloride)
Hide Arm/Group Description

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.

Regorafenib: Given PO

Gemcitabine Hydrochloride: Given IV

Period Title: Overall Study
Started 2
Completed 0
Not Completed 2
Reason Not Completed
Disease progression             2
Arm/Group Title Treatment (Regorafenib, Gemcitabine Hydrochloride)
Hide Arm/Group Description

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.

Regorafenib: Given PO

Gemcitabine Hydrochloride: Given IV

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
2
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
2
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
1.Primary Outcome
Title Progression-free Survival
Hide Description Time-to-event data will be summarized using the Kaplan-Meier method.
Time Frame Up to 1 year from enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome, study terminated early due to low accrual.
Arm/Group Title Treatment (Regorafenib, Gemcitabine Hydrochloride)
Hide Arm/Group Description:

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.

Regorafenib: Given PO

Gemcitabine Hydrochloride: Given IV

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events collected up to 3 months while on treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Regorafenib, Gemcitabine Hydrochloride)
Hide Arm/Group Description

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.

Regorafenib: Given PO

Gemcitabine Hydrochloride: Given IV

All-Cause Mortality
Treatment (Regorafenib, Gemcitabine Hydrochloride)
Affected / at Risk (%)
Total   2/2 (100.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Regorafenib, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Gastrointestinal disorders   
Colitis * 1  1/2 (50.00%)  1
Nausea * 1  1/2 (50.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign * 1  1/2 (50.00%)  1
Vascular disorders   
Hepatic Vein Thrombus * 1  1/2 (50.00%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Regorafenib, Gemcitabine Hydrochloride)
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Gastrointestinal disorders   
Abdominal Pain * 1  1/2 (50.00%)  1
Colitis * 1  1/2 (50.00%)  1
Intermittent Nausea * 1  1/2 (50.00%)  1
General disorders   
Intermittent Fatigue * 1  1/2 (50.00%)  1
Infections and infestations   
Infections, other : Thrush mouth * 1  1/2 (50.00%)  1
Sinusitis * 1  1/2 (50.00%)  1
Investigations   
Alkaline phosphatase increased * 1  1/2 (50.00%)  2
alkaline phosphatase, increased gr1 * 1  1/2 (50.00%)  1
ALT increased * 1  1/2 (50.00%)  8
ALT increased, gr1 * 1  1/2 (50.00%)  1
Aspartate Aminotransferase Increased * 1  1/2 (50.00%)  1
AST increased * 1  1/2 (50.00%)  1
decreased platelets * 1  1/2 (50.00%)  1
increased ALT * 1  1/2 (50.00%)  1
Increased creatinine * 1  1/2 (50.00%)  1
Increased Lipase * 1  1/2 (50.00%)  1
Leukopenia, gr1 * 1  1/2 (50.00%)  1
Lymphocyte Count decreased * 1  1/2 (50.00%)  1
neutropenia * 1  1/2 (50.00%)  1
platelet count decreased * 1  1/2 (50.00%)  1
Thombocytopenia * 1  1/2 (50.00%)  1
Thrombocytopenia * 1  1/2 (50.00%)  1
Thrombocytopenia, gr1 * 1  1/2 (50.00%)  1
Weight Gain * 1  1/2 (50.00%)  1
Weight Loss * 1  1/2 (50.00%)  1
White blood cell count decreased * 1  1/2 (50.00%)  1
Metabolism and nutrition disorders   
Anorexia * 1  1/2 (50.00%)  1
Dehydration * 1  1/2 (50.00%)  1
Hyperglycemia * 1  1/2 (50.00%)  2
Hyperglycemia, gr1 * 1  1/2 (50.00%)  1
Hypoalbuminemia * 1  1/2 (50.00%)  1
Hypokalemia * 1  1/2 (50.00%)  2
Hyponatremia * 1  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
muscle soreness, R shoulder, gr1 * 1  1/2 (50.00%)  1
Neck Pain * 1  1/2 (50.00%)  1
Nervous system disorders   
Dizziness * 1  1/2 (50.00%)  1
Headache * 1  1/2 (50.00%)  2
Sinus Pain * 1  1/2 (50.00%)  1
Psychiatric disorders   
depression * 1  1/2 (50.00%)  1
Renal and urinary disorders   
Proteinuria * 1  1/2 (50.00%)  2
Skin and subcutaneous tissue disorders   
Petechial Rash, gr1 * 1  1/2 (50.00%)  1
pruritis * 1  1/2 (50.00%)  1
pruritis, gr1 * 1  1/2 (50.00%)  1
sunburn * 1  1/2 (50.00%)  1
Vascular disorders   
Hepatic Vein Thrombosis * 1  1/2 (50.00%)  1
hypertension * 1  1/2 (50.00%)  6
Intermittent Hypertension * 1  1/2 (50.00%)  1
worsening hypertension, gr2 * 1  1/2 (50.00%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Data was not collected, study terminated early due to low accrual.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Davendra Sohal
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: +1 216-444-8258
EMail: sohald@ccf.org
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02383433     History of Changes
Other Study ID Numbers: CASE5214
NCI-2015-00146 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE5214 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2015
First Posted: March 9, 2015
Results First Submitted: March 22, 2019
Results First Posted: May 10, 2019
Last Update Posted: May 10, 2019