Trial Outcomes & Findings for Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer (NCT NCT02383433)
NCT ID: NCT02383433
Last Updated: 2023-10-23
Results Overview
Time-to-event data will be summarized using the Kaplan-Meier method.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
Up to 1 year from enrollment
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
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.
Regorafenib: Given PO
Gemcitabine Hydrochloride: Given IV
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
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.
Regorafenib: Given PO
Gemcitabine Hydrochloride: Given IV
|
|---|---|
|
Overall Study
Disease progression
|
2
|
Baseline Characteristics
Regorafenib Plus Gemcitabine in Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Regorafenib, Gemcitabine Hydrochloride)
n=2 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year from enrollmentPopulation: Data was not collected for this outcome, study terminated early due to low accrual.
Time-to-event data will be summarized using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Regorafenib, Gemcitabine Hydrochloride)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Regorafenib, Gemcitabine Hydrochloride)
n=2 participants at risk
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
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Gastrointestinal disorders
Colitis
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Vascular disorders
Hepatic Vein Thrombus
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
Other adverse events
| Measure |
Treatment (Regorafenib, Gemcitabine Hydrochloride)
n=2 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Alkaline phosphatase increased
|
50.0%
1/2 • Number of events 2 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
alkaline phosphatase, increased gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
ALT increased
|
50.0%
1/2 • Number of events 8 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
ALT increased, gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
AST increased
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Gastrointestinal disorders
Colitis
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
decreased platelets
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Psychiatric disorders
depression
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 2 • Adverse events collected up to 3 months while on treatment.
|
|
Vascular disorders
Hepatic Vein Thrombosis
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
50.0%
1/2 • Number of events 2 • Adverse events collected up to 3 months while on treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia, gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Vascular disorders
hypertension
|
50.0%
1/2 • Number of events 6 • Adverse events collected up to 3 months while on treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 2 • Adverse events collected up to 3 months while on treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
increased ALT
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Increased creatinine
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Increased Lipase
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Infections and infestations
Infections, other : Thrush mouth
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
General disorders
Intermittent Fatigue
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Vascular disorders
Intermittent Hypertension
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Gastrointestinal disorders
Intermittent Nausea
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Leukopenia, gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Lymphocyte Count decreased
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Musculoskeletal and connective tissue disorders
muscle soreness, R shoulder, gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
neutropenia
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Skin and subcutaneous tissue disorders
Petechial Rash, gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
platelet count decreased
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
1/2 • Number of events 2 • Adverse events collected up to 3 months while on treatment.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Skin and subcutaneous tissue disorders
pruritis, gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Nervous system disorders
Sinus Pain
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Infections and infestations
Sinusitis
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Skin and subcutaneous tissue disorders
sunburn
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Thombocytopenia
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Thrombocytopenia
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Thrombocytopenia, gr1
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Weight Gain
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
Weight Loss
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Investigations
White blood cell count decreased
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
|
Vascular disorders
worsening hypertension, gr2
|
50.0%
1/2 • Number of events 1 • Adverse events collected up to 3 months while on treatment.
|
Additional Information
Davendra Sohal
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: +1 216-444-8258
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place