Trial Outcomes & Findings for Vandetanib in Preventing Head and Neck Cancer in Patients With Precancerous Head and Neck Lesions (NCT NCT01414426)
NCT ID: NCT01414426
Last Updated: 2021-01-14
Results Overview
A Wilcoxon ranksum test may be used if the normality assumption is not satisfied. Alternatively, change in MVD may be transformed (e.g. log-transformation) to satisfy the normality assumption. Additional analyses will include linear regression models with treatment effect and other prognostic factors as covariates.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2021-01-14
Participant Flow
Participant milestones
| Measure |
Arm I (Chemoprevention)
Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
vandetanib: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo)
Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vandetanib in Preventing Head and Neck Cancer in Patients With Precancerous Head and Neck Lesions
Baseline characteristics by cohort
| Measure |
Arm I (Chemoprevention)
n=10 Participants
Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
vandetanib: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo)
n=10 Participants
Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
49.0 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
54.8 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsPopulation: The outcome measure microvessel density was not collected on any subjects
A Wilcoxon ranksum test may be used if the normality assumption is not satisfied. Alternatively, change in MVD may be transformed (e.g. log-transformation) to satisfy the normality assumption. Additional analyses will include linear regression models with treatment effect and other prognostic factors as covariates.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly during treatment, up to week 24Adverse events rate shows the total number of subjects with an AE.
Outcome measures
| Measure |
Arm I (Chemoprevention)
n=10 Participants
Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
vandetanib: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo)
n=10 Participants
Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Number of Participants With Adverse Events
Week 16
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Week 17
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Week 1
|
3 participants
|
6 participants
|
|
Number of Participants With Adverse Events
Week 2
|
4 participants
|
3 participants
|
|
Number of Participants With Adverse Events
Week 3
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Week 4
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 5
|
5 participants
|
5 participants
|
|
Number of Participants With Adverse Events
Week 6
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Week 7
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 8
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 9
|
7 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Week 10
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Week 11
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 12
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 13
|
3 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 14
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 15
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 18
|
0 participants
|
2 participants
|
|
Number of Participants With Adverse Events
Week 19
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 20
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Week 21
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 22
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events
Week 23
|
2 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 24
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events
Week 25
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Over 6 monthsNumber of participants who Adhered to Treatment
Outcome measures
| Measure |
Arm I (Chemoprevention)
n=10 Participants
Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
vandetanib: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo)
n=10 Participants
Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Number of Participants Who Adhered to Treatment
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: At 6, 9, and 12 months and then ever 6 months for 2 yearsNumber of patients with new cancer
Outcome measures
| Measure |
Arm I (Chemoprevention)
n=10 Participants
Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
vandetanib: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo)
n=10 Participants
Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Development of Oral and Other Cancers
9 months
|
0 participants
|
0 participants
|
|
Development of Oral and Other Cancers
6 months
|
1 participants
|
0 participants
|
|
Development of Oral and Other Cancers
12 months
|
0 participants
|
0 participants
|
|
Development of Oral and Other Cancers
18 Months
|
0 participants
|
0 participants
|
|
Development of Oral and Other Cancers
24 Months
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 3 and 6 monthsPopulation: Outcome measure was not collected.
Effect of treatment on EGFR and VEGFR2 inhibition
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Chemoprevention)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Chemoprevention)
n=10 participants at risk
Patients receive vandetanib PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
vandetanib: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
Arm II (Placebo)
n=10 participants at risk
Patients receive placebo PO QD for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
immunohistochemistry staining method: Correlative studies
laboratory biomarker analysis: Correlative studies
biopsy: Correlative studies
pharmacological study: Correlative studies
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
60.0%
6/10 • Number of events 8 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
40.0%
4/10 • Number of events 6 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Product Issues
General
|
40.0%
4/10 • Number of events 5 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
30.0%
3/10 • Number of events 5 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Infections and infestations
Infections
|
10.0%
1/10 • Number of events 1 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
10.0%
1/10 • Number of events 1 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Metabolism and nutrition disorders
Metabolic
|
10.0%
1/10 • Number of events 1 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/10 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Musculoskeletal and connective tissue disorders
Muscular
|
0.00%
0/10 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
20.0%
2/10 • Number of events 3 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Nervous system disorders
Nervous System
|
20.0%
2/10 • Number of events 3 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
10.0%
1/10 • Number of events 1 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Psychiatric disorders
Psychiatric
|
0.00%
0/10 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
20.0%
2/10 • Number of events 2 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Renal and urinary disorders
Renal
|
10.0%
1/10 • Number of events 1 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
0.00%
0/10 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Skin and subcutaneous tissue disorders
Skin
|
30.0%
3/10 • Number of events 4 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
30.0%
3/10 • Number of events 5 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
|
Vascular disorders
Vascular
|
20.0%
2/10 • Number of events 4 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
10.0%
1/10 • Number of events 1 • 180 days
Adverse Events were monitored/assessed without regard to the specific Adverse Event Term
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place