Trial Outcomes & Findings for Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer (NCT NCT01606124)
NCT ID: NCT01606124
Last Updated: 2017-10-27
Results Overview
The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
6 months
Results posted on
2017-10-27
Participant Flow
The study was closed to accrual early due to a pending expiration of the supply of study agent.
Participant milestones
| Measure |
Arm I (Polyphenon E)
Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo)
Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Polyphenon E)
n=19 Participants
Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo)
n=20 Participants
Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
59.9 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Patients with baseline and 6-month ACF data were included in this analysis.
The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.
Outcome measures
| Measure |
Arm I (Polyphenon E)
n=15 Participants
Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo)
n=17 Participants
Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Percent Change in Rectal ACF, Pre- and Post Intervention at 6 Months
|
3.7 percentage change
Standard Deviation 49.1
|
0.0 percentage change
Standard Deviation 62.7
|
SECONDARY outcome
Timeframe: 6 monthsTolerability as estimated using the percent dose of treatment received for each patient by dividing the total dose received by the targeted (i.e., protocol specified) total dose.
Outcome measures
| Measure |
Arm I (Polyphenon E)
n=19 Participants
Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo)
n=20 Participants
Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Tolerability as Estimated Using the Percent Dose of Treatment Received at 6 Months
|
83.2 percentage of targeted dose
Standard Deviation 29.3
|
91.7 percentage of targeted dose
Standard Deviation 24.0
|
Adverse Events
Arm I (Polyphenon E)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Polyphenon E)
n=19 participants at risk
Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
Arm II (Placebo)
n=20 participants at risk
Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Diarrhea
|
5.3%
1/19 • Number of events 1 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/20 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • Number of events 2 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Fatigue
|
0.00%
0/19 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
General disorders
Flu like symptoms
|
0.00%
0/19 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • Number of events 1 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/20 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • Number of events 1 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
0.00%
0/20 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/19 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
5.0%
1/20 • Number of events 6 • 6 months
CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place