Trial Outcomes & Findings for Adjuvant Aflibercept for Metastatic Colorectal Cancer (NCT NCT01669720)
NCT ID: NCT01669720
Last Updated: 2020-02-17
Results Overview
Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Every 3 months until disease progression (for up to 2 years).
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Aflibercept
Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years
|
Observation
Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
7
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjuvant Aflibercept for Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Aflibercept
n=7 Participants
Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years
|
Observation
n=3 Participants
Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
53.5 years
n=5 Participants
|
57 years
n=7 Participants
|
54.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 3 months until disease progression (for up to 2 years).Disease free survival in patients with advanced colorectal cancer who have undergone resection/ablation of all metastatic sites.
Outcome measures
| Measure |
Aflibercept
n=7 Participants
Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years
|
Observation
n=3 Participants
Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
|
|---|---|---|
|
Number of Patients Who Progressed
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Throughout study treatment until 30 days post off study, approximately 2 yearsPopulation: Data table reflects total number of patients who experienced a toxicity on study.
Toxicity defined by CTCAE Version 4.0 toxicities
Outcome measures
| Measure |
Aflibercept
n=7 Participants
Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years
|
Observation
n=3 Participants
Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
|
|---|---|---|
|
Number of Participants Who Experienced a Toxicity Profile of Adjuvant Ziv-aflibercept, up to 2-years of Duration, for Patients Who Previously Received Systemic Perioperative Therapy (Regimen) and Surgical Resection/Ablation.
|
6 Participants
|
2 Participants
|
Adverse Events
Aflibercept
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Observation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aflibercept
n=7 participants at risk
Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years
Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years
|
Observation
n=3 participants at risk
Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
|
|---|---|---|
|
Investigations
HTN
|
85.7%
6/7 • Number of events 6 • Every 2 weeks until 30 days post last dose of drug
|
33.3%
1/3 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Bronchial infection
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
UTI
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
ALK
|
57.1%
4/7 • Number of events 4 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Glu
|
85.7%
6/7 • Number of events 6 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
proteinuria
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
PLT
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
33.3%
1/3 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
AST
|
42.9%
3/7 • Number of events 3 • Every 2 weeks until 30 days post last dose of drug
|
33.3%
1/3 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
ALT
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
33.3%
1/3 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
bruising
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Hoarseness
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
akathisia/restlessness
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
cough
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
fever
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
rash
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Anemia
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
fatigue
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
lymph
|
42.9%
3/7 • Number of events 3 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Sodium
|
42.9%
3/7 • Number of events 3 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Edema- localized
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
pain-hip/leg, mouth, abd
|
71.4%
5/7 • Number of events 5 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
headache
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
mucositis
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
creatinine
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
WBC
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
dizziness
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
neuropathy
|
28.6%
2/7 • Number of events 2 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
arthralgia
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
weight gain
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
constipation
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
vision-blurry
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
increased hemoglobin
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
insomnia
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
anorexia
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Anxiety
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
|
Investigations
Hypokalemia
|
14.3%
1/7 • Number of events 1 • Every 2 weeks until 30 days post last dose of drug
|
0.00%
0/3 • Every 2 weeks until 30 days post last dose of drug
|
Additional Information
Howard Safran, MD
Brown University Oncology Research Group (BrUOG)
Phone: 4018633000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place