Trial Outcomes & Findings for A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer (NCT NCT02402036)
NCT ID: NCT02402036
Last Updated: 2019-01-29
Results Overview
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
2 years
Results posted on
2019-01-29
Participant Flow
Participant milestones
| Measure |
Regorafenib
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Regorafenib: Regorafenib orally for 21 days every 28 day cycle
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Regorafenib
n=10 Participants
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Regorafenib: Regorafenib orally for 21 days every 28 day cycle
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Due to issues with recruitment and the principal investigator leaving the institution, no analysis of the collected samples was performed.
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Outcome measures
Outcome data not reported
Adverse Events
Regorafenib
Serious events: 5 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Regorafenib
n=10 participants at risk
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Regorafenib: Regorafenib orally for 21 days every 28 day cycle
|
|---|---|
|
General disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Gastrointestinal disorders
Colonic Obstruction
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Hyponatremia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
2/10 • Number of events 2 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
Other adverse events
| Measure |
Regorafenib
n=10 participants at risk
Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle
Regorafenib: Regorafenib orally for 21 days every 28 day cycle
|
|---|---|
|
General disorders
Abdominal Pain
|
50.0%
5/10 • Number of events 7 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Alkaline phosphatase increased
|
30.0%
3/10 • Number of events 3 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 3 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
30.0%
3/10 • Number of events 5 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Gastrointestinal disorders
Colonic obstruction
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Renal and urinary disorders
Creatinine increased
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Hepatobiliary disorders
Elevated total bilirrubin
|
20.0%
2/10 • Number of events 3 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Immune system disorders
High Neutrophils
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
40.0%
4/10 • Number of events 7 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Hyponatremia
|
20.0%
2/10 • Number of events 3 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Blood and lymphatic system disorders
PT increased
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Immune system disorders
WBC increased
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
20.0%
2/10 • Number of events 3 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Fatigue
|
60.0%
6/10 • Number of events 7 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
50.0%
5/10 • Number of events 8 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Metabolism and nutrition disorders
Weight loss
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Dehydration
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • Number of events 3 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Hoarseness
|
20.0%
2/10 • Number of events 2 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Immune system disorders
Lymphocyte count decreased
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Blood and lymphatic system disorders
Nasal bleed
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Pain
|
30.0%
3/10 • Number of events 6 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
General disorders
Hot flashes
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Tooth development disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion up to 1 year of treatment and safety follow-up. The period of collection depended on the length of the treatment period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place