Trial Outcomes & Findings for Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer (NCT NCT02654639)
NCT ID: NCT02654639
Last Updated: 2018-08-07
Results Overview
Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
TAS-102 and Bevacizumab
Oral TAS-102 and intravenous Bevacizumab.
TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab: Bevacizumab by intravenous infusion once every 14 days
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ph 2 Study of TAS-102 / Bevacizumab Maintenance Therapy Post Induction Chemotherapy in Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
TAS-102 and Bevacizumab
n=4 Participants
Oral TAS-102 and intravenous Bevacizumab.
TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab: Bevacizumab by intravenous infusion once every 14 days
|
|---|---|
|
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
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first occurrence of progression or death, whichever occurred first, assessed up to 2 years.Population: The study was terminated early due to recruitment difficulties. 4 subjects were enrolled but no outcomes data was collected and no analysis was performed.
Disease progression will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI.
Outcome measures
Outcome data not reported
Adverse Events
TAS-102 and Bevacizumab
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAS-102 and Bevacizumab
n=4 participants at risk
Oral TAS-102 and intravenous Bevacizumab.
TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab: Bevacizumab by intravenous infusion once every 14 days
|
|---|---|
|
Immune system disorders
Neutropenia
|
25.0%
1/4 • Number of events 2 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
Other adverse events
| Measure |
TAS-102 and Bevacizumab
n=4 participants at risk
Oral TAS-102 and intravenous Bevacizumab.
TAS-102: TAS-102 Twice a day by mouth day 1-5 and 8-12
Bevacizumab: Bevacizumab by intravenous infusion once every 14 days
|
|---|---|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Immune system disorders
Neutrophil count decreased
|
50.0%
2/4 • Number of events 4 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Nervous system disorders
Nervous system disorders - Other
|
25.0%
1/4 • Number of events 2 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Hepatobiliary disorders
Hepatic failure
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Skin and subcutaneous tissue disorders
Dysgeusia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 2 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
|
Immune system disorders
White blood cell decreased
|
25.0%
1/4 • Number of events 3 • Adverse events were collected for each subject from the time they signed the informed consent until study completion. The period of collection depended on the length of the treatment period. Across all subjects enrolled, this amounted to 8.75 months of AE collection on average.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place