Trial Outcomes & Findings for Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC (NCT NCT03099486)
NCT ID: NCT03099486
Last Updated: 2022-02-07
Results Overview
PFS at 2 months in mCRC patients who progress on regorafenib monotherapy and are treated with regorafenib and 5-FU/LV combination therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
2 months
Results posted on
2022-02-07
Participant Flow
Participant milestones
| Measure |
Regorafenib + 5FU/LV Treatment Arm
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regorafenib Plus 5-Fluorouracil/Leucovorin Beyond Progression in mCRC
Baseline characteristics by cohort
| Measure |
Regorafenib + 5FU/LV Treatment Arm
n=2 Participants
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 monthsPFS at 2 months in mCRC patients who progress on regorafenib monotherapy and are treated with regorafenib and 5-FU/LV combination therapy.
Outcome measures
| Measure |
Regorafenib + 5FU/LV Treatment Arm
n=2 Participants
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Progression Free Survival (PFS) at 2 Months
|
NA months
Study was halted prematurely due to low accrual, not enough data obtained for analysis.
|
SECONDARY outcome
Timeframe: 1 yearsOverall survival will be calculated from the day of first treatment until death
Outcome measures
| Measure |
Regorafenib + 5FU/LV Treatment Arm
n=2 Participants
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Overall Survival Rate
|
NA months
Study was halted prematurely due to low accrual, not enough data obtained for analysis.
|
SECONDARY outcome
Timeframe: 1-2 yearsThis will be calculated from the day of first treatment dose until disease progression or death, whichever occurs earlier
Outcome measures
| Measure |
Regorafenib + 5FU/LV Treatment Arm
n=2 Participants
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Best Overall Response
|
NA Participants
Study was halted prematurely due to low accrual, not enough data obtained for analysis.
|
SECONDARY outcome
Timeframe: 1-2 yearsNumber of toxicities due to combination therapy will be summarized by frequencies and grades of toxicities due to the combination therapy according to CTCAE 4.03 criteria
Outcome measures
| Measure |
Regorafenib + 5FU/LV Treatment Arm
n=2 Participants
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Number of Toxicities Due to Regorafenib and 5-FU/LV Combination Therapy
|
NA toxicities
Study was halted prematurely due to low accrual, not enough data obtained for analysis.
|
Adverse Events
Regorafenib + 5FU/LV Treatment Arm
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Regorafenib + 5FU/LV Treatment Arm
n=2 participants at risk
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Blood and lymphatic system disorders
Moderate Congestive Heart Failure
|
50.0%
1/2 • 3 years
|
Other adverse events
| Measure |
Regorafenib + 5FU/LV Treatment Arm
n=2 participants at risk
Regorafenib: The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
5-FU: 5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
Leucovorin: D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
2/2 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
100.0%
2/2 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Bloating
|
50.0%
1/2 • 3 years
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
50.0%
1/2 • 3 years
|
|
General disorders
Fatigue
|
100.0%
2/2 • 3 years
|
|
General disorders
Chills
|
50.0%
1/2 • 3 years
|
|
General disorders
Edema Limbs
|
50.0%
1/2 • 3 years
|
|
General disorders
Fever
|
50.0%
1/2 • 3 years
|
|
General disorders
Pain
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Infection
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Upper Respiratory Infection
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Urinary Tract Infection
|
50.0%
1/2 • 3 years
|
|
Infections and infestations
Wound Infection
|
50.0%
1/2 • 3 years
|
|
Investigations
Weight Loss
|
100.0%
2/2 • 3 years
|
|
Investigations
Neutrophil Count Decreased
|
50.0%
1/2 • 3 years
|
|
Investigations
Platelet Count Decreased
|
50.0%
1/2 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
2/2 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
2/2 • 3 years
|
|
Nervous system disorders
Dizziness
|
100.0%
2/2 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
100.0%
2/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
1/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarsness
|
50.0%
1/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
50.0%
1/2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
50.0%
1/2 • 3 years
|
|
Vascular disorders
Hypertension
|
100.0%
2/2 • 3 years
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • 3 years
|
|
Cardiac disorders
Heart Failure
|
50.0%
1/2 • 3 years
|
|
Ear and labyrinth disorders
Ear Pain
|
50.0%
1/2 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
50.0%
1/2 • 3 years
|
|
Psychiatric disorders
Agitation
|
50.0%
1/2 • 3 years
|
|
Psychiatric disorders
Insomnia
|
50.0%
1/2 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
50.0%
1/2 • 3 years
|
|
Renal and urinary disorders
Urinary Frequency
|
50.0%
1/2 • 3 years
|
|
Renal and urinary disorders
Urinary Urgency
|
50.0%
1/2 • 3 years
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
50.0%
1/2 • 3 years
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
50.0%
1/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
50.0%
1/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
50.0%
1/2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
50.0%
1/2 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place