Trial Outcomes & Findings for A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer (NCT NCT00730158)
NCT ID: NCT00730158
Last Updated: 2019-05-22
Results Overview
The proportion of participants with a toxicity grade greater than or equal to grade 2, per NCI CTCAE 4.0. Toxicity is defined as any adverse event (AE) at least probably related to treatment occurring with 90 days of the beginning of treatment. The worst grade of AE at least probably related to treatment was determined for each participant.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Up to 3 months after start of study treatment
Results posted on
2019-05-22
Participant Flow
Participant milestones
| Measure |
Irinotecan+ KD018
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Irinotecan + Placebo
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Irinotecan+ KD018
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Irinotecan + Placebo
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Irinotecan+ KD018
n=16 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Irinotecan + Placebo
n=15 Participants
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
61.7 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months after start of study treatmentPopulation: Participants that received at least 3 months of study treatment.
The proportion of participants with a toxicity grade greater than or equal to grade 2, per NCI CTCAE 4.0. Toxicity is defined as any adverse event (AE) at least probably related to treatment occurring with 90 days of the beginning of treatment. The worst grade of AE at least probably related to treatment was determined for each participant.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=16 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=15 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Proportion of Participants With Grade 2-4 Toxicities
|
0.63 proportion of participants
Interval 0.35 to 0.85
|
0.40 proportion of participants
Interval 0.16 to 0.68
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Participants evaluable for response.
Number of participants who experienced a best response of Partial Response (PR) or Stable Disease (SD) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1), PR is \>=30% decrease in the sum of the longest diameter of target lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameter.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=12 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Overall Response (OR)
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Up to 450 daysPopulation: Patients that were evaluable for response and survival data were obtainable.
Median number of days and after the treatment participants remained alive without worsening disease. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=12 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=14 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
122 Days
Interval 106.0 to
Statistically Not Reached.
|
104 Days
Interval 52.0 to 242.0
|
SECONDARY outcome
Timeframe: Up to 900 daysPopulation: All participants.
Median number of days from the start of treatment that study participants remained alive.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=16 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=15 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
291 Days
Interval 174.0 to
Statistically Not Reached
|
482 Days
Interval 308.0 to
Statistically Not Reached
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Participants that were evaluable for response.
Number of patients that experienced Progressed Disease, Stable Disease or Partial Response per RECIST 1.1. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters, and Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=12 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Clinical Response (CR)
Progressed Disease
|
7 participants
|
2 participants
|
|
Clinical Response (CR)
Stable Disease
|
5 participants
|
9 participants
|
|
Clinical Response (CR)
Partial Response
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).
The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. The Functional Assessment of Chronic Illness Therapy (Diarrhea), the FACIT-D, contains 11 items which address concerns related to treatment-related diarrhea. Responses are on a Likert scale and range from 0 = "Not at all" to 4 = "Very Much". Thus, total scores can range from 0 to 44. Higher scores relate to better functioning.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=12 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=13 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 0
|
40.09 score on a scale
Interval 36.02 to 44.16
|
39.77 score on a scale
Interval 36.98 to 42.56
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 1
|
37.66 score on a scale
Interval 34.37 to 40.95
|
35.55 score on a scale
Interval 30.98 to 40.12
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 2
|
34.78 score on a scale
Interval 28.57 to 40.98
|
37.78 score on a scale
Interval 33.09 to 42.47
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 3
|
37.75 score on a scale
Interval 32.64 to 42.86
|
35.65 score on a scale
Interval 29.48 to 41.82
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 4
|
35.62 score on a scale
Interval 30.1 to 41.15
|
35.71 score on a scale
Interval 29.89 to 41.53
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 5
|
37.09 score on a scale
Interval 29.93 to 44.24
|
31.25 score on a scale
Interval 25.53 to 36.97
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 6
|
36.54 score on a scale
Interval 29.52 to 43.57
|
30.38 score on a scale
Interval 19.3 to 41.47
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 7
|
38.60 score on a scale
Interval 31.49 to 45.71
|
29.33 score on a scale
Interval 19.06 to 39.61
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 8
|
38.50 score on a scale
Interval 23.1 to 53.9
|
28.20 score on a scale
Interval 18.14 to 38.26
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 9
|
35.67 score on a scale
Interval 16.69 to 54.64
|
32.50 score on a scale
Interval 0.73 to 64.27
|
|
The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Cycle 10
|
30.00 score on a scale
Interval 4.59 to 55.41
|
31.50 score on a scale
Interval -25.68 to 88.68
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being is a 7-item subscale score of the total FACIT-D self-assessment that measures a patient's physical well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better physical well-being.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=14 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 0
|
23.18 score on a scale
Interval 21.09 to 25.27
|
21.79 score on a scale
Interval 18.14 to 25.43
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 1
|
21.69 score on a scale
Interval 17.7 to 25.68
|
22.00 score on a scale
Interval 18.64 to 25.36
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 2
|
22.00 score on a scale
Interval 18.27 to 25.73
|
22.21 score on a scale
Interval 18.64 to 25.78
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 3
|
24.26 score on a scale
Interval 22.4 to 26.12
|
21.30 score on a scale
Interval 17.18 to 25.42
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 4
|
22.67 score on a scale
Interval 20.12 to 25.22
|
23.09 score on a scale
Interval 20.62 to 25.56
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 5
|
23.62 score on a scale
Interval 20.95 to 26.3
|
21.88 score on a scale
Interval 17.08 to 26.67
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 6
|
23.50 score on a scale
Interval 21.09 to 25.91
|
20.00 score on a scale
Interval 14.37 to 25.22
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 7
|
22.14 score on a scale
Interval 19.67 to 24.61
|
20.83 score on a scale
Interval 16.31 to 25.36
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 8
|
22.67 score on a scale
Interval 19.37 to 25.96
|
17.40 score on a scale
Interval 11.81 to 22.99
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 9
|
22.00 score on a scale
Interval 15.64 to 28.36
|
22.50 score on a scale
Interval -9.27 to 54.27
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Cycle 10
|
23.33 score on a scale
Interval 10.83 to 35.84
|
23.50 score on a scale
Interval 17.15 to 29.85
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle (every 2 weeks).
The Functional Assessment of Chronic Illness Therapy FACIT-D Emotional Well-Being (EWB) is a 6-item subscale score of the total FACIT-D self-assessment that measures a patient's emotional well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-24. Higher scores related to better emotional well-being.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=14 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 0
|
19.85 score on a scale
Interval 17.87 to 21.82
|
16.43 score on a scale
Interval 13.48 to 19.38
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 1
|
18.00 score on a scale
Interval 15.19 to 20.81
|
16.43 score on a scale
Interval 13.33 to 19.53
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 2
|
19.96 score on a scale
Interval 17.36 to 22.55
|
17.30 score on a scale
Interval 14.06 to 20.54
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 3
|
20.11 score on a scale
Interval 17.52 to 22.7
|
17.76 score on a scale
Interval 14.11 to 21.41
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 4
|
19.33 score on a scale
Interval 16.76 to 21.91
|
19.55 score on a scale
Interval 17.39 to 21.7
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 5
|
20.38 score on a scale
Interval 17.81 to 22.94
|
18.75 score on a scale
Interval 15.22 to 22.28
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 6
|
19.88 score on a scale
Interval 17.53 to 22.22
|
17.20 score on a scale
Interval 11.35 to 23.05
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 7
|
20.57 score on a scale
Interval 18.25 to 22.89
|
17.80 score on a scale
Interval 12.95 to 22.65
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 8
|
20.33 score on a scale
Interval 17.88 to 22.79
|
15.50 score on a scale
Interval 6.0 to 25.0
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 9
|
21.25 score on a scale
Interval 16.87 to 25.63
|
21.00 score on a scale
Interval -4.41 to 46.41
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Cycle 10
|
22.00 score on a scale
Interval 17.03 to 26.97
|
20.30 score on a scale
Interval 3.78 to 36.82
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.
The Functional Assessment of Chronic Illness Therapy FACIT-D Social Well-Being (SWB) is a 7-item subset score of the total FACIT-D self-assessment that measures a patient's social well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better social well-being.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=14 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 0
|
25.85 score on a scale
Interval 24.74 to 26.96
|
23.91 score on a scale
Interval 20.52 to 27.29
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 1
|
21.46 score on a scale
Interval 17.01 to 25.92
|
24.33 score on a scale
Interval 21.3 to 27.36
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 2
|
20.74 score on a scale
Interval 14.07 to 27.41
|
25.60 score on a scale
Interval 23.7 to 27.5
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 3
|
25.09 score on a scale
Interval 22.16 to 28.03
|
25.33 score on a scale
Interval 23.74 to 26.91
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 4
|
23.43 score on a scale
Interval 20.17 to 26.68
|
24.60 score on a scale
Interval 21.23 to 27.97
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 5
|
25.07 score on a scale
Interval 21.71 to 28.44
|
24.29 score on a scale
Interval 19.09 to 29.49
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 6
|
22.19 score on a scale
Interval 15.33 to 29.04
|
23.60 score on a scale
Interval 21.9 to 24.21
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 7
|
25.83 score on a scale
Interval 21.76 to 29.91
|
22.89 score on a scale
Interval 19.05 to 26.73
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 8
|
24.22 score on a scale
Interval 19.58 to 28.87
|
21.63 score on a scale
Interval 15.45 to 27.82
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 9
|
25.67 score on a scale
Interval 20.42 to 30.92
|
23.00 score on a scale
Interval -2.41 to 48.41
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Cycle 10
|
24.94 score on a scale
Interval 14.21 to 35.68
|
23.50 score on a scale
Interval -8.27 to 55.27
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.
The Functional Assessment of Chronic Illness Therapy FACIT-D Functional Well-Being (FWB) is a 7-item subscale of the FACIT-D that measures a patient's functional well-being. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-28. Higher scores related to better family well-being.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=14 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 0
|
19.85 score on a scale
Interval 16.48 to 23.21
|
18.07 score on a scale
Interval 14.44 to 21.7
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 1
|
18.89 score on a scale
Interval 14.62 to 23.17
|
17.21 score on a scale
Interval 13.84 to 20.59
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 2
|
19.78 score on a scale
Interval 15.43 to 24.97
|
20.20 score on a scale
Interval 14.46 to 25.1
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 3
|
20.11 score on a scale
Interval 15.59 to 24.63
|
19.32 score on a scale
Interval 14.33 to 24.3
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 4
|
19.44 score on a scale
Interval 15.47 to 23.42
|
19.09 score on a scale
Interval 14.86 to 23.32
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 5
|
19.77 score on a scale
Interval 16.09 to 23.46
|
20.50 score on a scale
Interval 10.56 to 30.44
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 6
|
19.62 score on a scale
Interval 15.48 to 23.77
|
17.00 score on a scale
Interval 10.31 to 23.69
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 7
|
19.00 score on a scale
Interval 12.98 to 25.02
|
16.40 score on a scale
Interval 10.74 to 22.06
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 8
|
19.83 score on a scale
Interval 14.85 to 24.82
|
17.00 score on a scale
Interval 7.19 to 26.81
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 9
|
22.58 score on a scale
Interval 7.19 to 26.81
|
20.50 score on a scale
Interval 14.85 to 24.82
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Cycle 10
|
21.00 score on a scale
Interval -35.68 to 78.68
|
21.50 score on a scale
Interval 2.25 to 39.75
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACT-G during any single treatment cycle.
The FACIT-D FACTG: FACT-G Total Score is a total of PWB (Physical Well-Being)+SWB (Social Well-Being)+EWB (Emotional Well-Being)+FWB (Functional Well-Being) subset scores. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-108. Higher scores indicate greater well-being.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=13 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=14 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 0
|
88.72 score on a scale
Interval 82.18 to 95.26
|
80.19 score on a scale
Interval 68.66 to 91.73
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 1
|
80.05 score on a scale
Interval 68.46 to 91.64
|
79.98 score on a scale
Interval 69.37 to 90.58
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 2
|
82.47 score on a scale
Interval 69.52 to 95.42
|
84.99 score on a scale
Interval 72.48 to 97.51
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 3
|
89.57 score on a scale
Interval 79.78 to 99.37
|
83.70 score on a scale
Interval 70.54 to 96.86
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 4
|
84.87 score on a scale
Interval 75.61 to 94.13
|
86.33 score on a scale
Interval 76.32 to 96.33
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 5
|
88.85 score on a scale
Interval 78.33 to 99.36
|
85.42 score on a scale
Interval 64.4 to 106.44
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 6
|
85.19 score on a scale
Interval 73.99 to 96.38
|
79.07 score on a scale
Interval 65.44 to 92.7
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 7
|
87.55 score on a scale
Interval 75.96 to 99.13
|
76.43 score on a scale
Interval 60.23 to 92.62
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 8
|
87.06 score on a scale
Interval 74.44 to 99.67
|
74.79 score on a scale
Interval 48.58 to 101.0
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 9
|
91.50 score on a scale
Interval 73.24 to 109.76
|
87.00 score on a scale
Interval -65.47 to 239.47
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Cycle 10
|
91.28 score on a scale
Interval 53.15 to 129.4
|
88.80 score on a scale
Interval -23.01 to 200.61
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score is a 13 -item self-reporting assessment that measures fatigue related to their illness. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score ranges from 0-52. Higher scores indicate better functioning.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=13 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=12 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 8
|
40.78 score on a scale
Interval 28.92 to 52.65
|
30.20 score on a scale
Interval 14.96 to 45.44
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 9
|
40.25 score on a scale
Interval 29.59 to 50.91
|
33.33 score on a scale
Interval -1.47 to 68.14
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 0
|
41.39 score on a scale
Interval 36.5 to 46.28
|
36.17 score on a scale
Interval 28.42 to 43.91
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 1
|
36.09 score on a scale
Interval 26.22 to 45.96
|
36.67 score on a scale
Interval 30.36 to 42.97
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 2
|
38.80 score on a scale
Interval 32.68 to 44.92
|
38.45 score on a scale
Interval 30.44 to 46.47
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 3
|
41.67 score on a scale
Interval 36.57 to 46.77
|
36.22 score on a scale
Interval 27.19 to 45.26
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 4
|
40.22 score on a scale
Interval 36.18 to 44.27
|
38.56 score on a scale
Interval 30.64 to 46.47
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 5
|
40.25 score on a scale
Interval 36.02 to 44.48
|
39.75 score on a scale
Interval 23.77 to 55.73
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 6
|
41.53 score on a scale
Interval 36.03 to 47.03
|
30.72 score on a scale
Interval 20.11 to 41.33
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 7
|
41.33 score on a scale
Interval 34.67 to 47.99
|
33.33 score on a scale
Interval 22.74 to 43.93
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Cycle 10
|
41.50 score on a scale
Interval 30.14 to 52.86
|
40.00 score on a scale
Interval -36.24 to 116.24
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index. is the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and "additional concerns" subscales of the FACIT-D. The TOI is an efficient summary index of physical/functional outcomes. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. Individual responses are scale and range from 0 = "Not at all" to 4 = "Very Much". The total score can range from 0-100. Higher scores relate to better functioning.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=13 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=12 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 0
|
82.03 score on a scale
Interval 75.36 to 88.7
|
79.23 score on a scale
Interval 71.42 to 87.04
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 1
|
78.01 score on a scale
Interval 68.39 to 87.63
|
75.17 score on a scale
Interval 66.46 to 83.89
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 2
|
76.56 score on a scale
Interval 62.84 to 90.27
|
82.42 score on a scale
Interval 72.85 to 91.98
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 3
|
81.88 score on a scale
Interval 71.97 to 91.78
|
76.27 score on a scale
Interval 62.73 to 89.8
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 4
|
77.12 score on a scale
Interval 68.15 to 86.1
|
79.11 score on a scale
Interval 67.99 to 90.23
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 5
|
80.40 score on a scale
Interval 67.97 to 92.82
|
73.62 score on a scale
Interval 56.42 to 90.83
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 6
|
79.11 score on a scale
Interval 68.09 to 90.14
|
66.46 score on a scale
Interval 47.02 to 85.9
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 7
|
82.00 score on a scale
Interval 67.33 to 96.67
|
65.40 score on a scale
Interval 47.27 to 83.53
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 8
|
81.25 score on a scale
Interval 55.74 to 106.76
|
61.50 score on a scale
Interval 33.62 to 89.38
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 9
|
80.44 score on a scale
Interval 38.37 to 122.52
|
75.50 score on a scale
Interval -57.92 to 208.92
|
|
The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Cycle 10
|
68.50 score on a scale
Interval -1.38 to 138.38
|
76.50 score on a scale
Interval -44.21 to 197.21
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Patients that received study treatment.
Number of patients with metabolites in their blood samples with a score less than 4.8 and greater than 4.8. A Cox Proportional Hazard Regression Analysis was fitted using survival time, status to the cytokines and metabolites as covariates. The analysis computes beta coefficients (hazard ratios) for each cytokine/metabolite. Scores higher than a threshold value of 4.8 were associated with higher overall survival than patients who scored less than 4.8.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=8 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=9 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression
Scores < 4.8 (two metabolites)
|
3 participants
|
3 participants
|
|
Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression
Scores > 4.8 (two metabolites)
|
5 participants
|
6 participants
|
|
Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression
Scores < 4.8 (one metabolite+two cytokine)
|
2 participants
|
4 participants
|
|
Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression
Scores > 4.8 (one metabolite+two cytokine)
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: From 30 minutes prior to irinotecan infusion through to Immediately after irinotecan infusion, up to 8 weeksPopulation: Patients who completed at least (3) treatment cycles.
The number of patients with specific polymorphisms of UGT1A1 using genotype analysis of peripheral blood sample. UGT1A1\*1 is the wild-type allele associated with normal enzyme activity. Patients with genotypic status of 7/7 are at an increased risk of neutropenia following intravenous irinotecan therapy.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=12 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles
genotype 5/6
|
0 number of participants
|
1 number of participants
|
|
Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles
genotype 6/6
|
4 number of participants
|
4 number of participants
|
|
Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles
genotype 6/7
|
5 number of participants
|
4 number of participants
|
|
Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles
genotype 7/7
|
0 number of participants
|
0 number of participants
|
SECONDARY outcome
Timeframe: Baseline - prior to treatmentPercentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=12 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Braf mutation
|
22 percentage of participants
|
22 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Kras mutation
|
66 percentage of participants
|
44 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Nras mutation
|
11 percentage of participants
|
0 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
PIK3CA mutation
|
22 percentage of participants
|
55 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
PTEN mutation
|
11 percentage of participants
|
11 percentage of participants
|
SECONDARY outcome
Timeframe: End of treatment - up to 8 weeksPercentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.
Outcome measures
| Measure |
Arm A - Irinotecan + KD018
n=14 Participants
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=12 Participants
Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Braf mutation
|
0 percentage of participants
|
22 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Kras mutation
|
33 percentage of participants
|
44 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Nras mutation
|
11 percentage of participants
|
11 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
PIK3CA mutation
|
22 percentage of participants
|
0 percentage of participants
|
|
Circulating Tumor DNA - Percentage of Patients With DNA Mutations
PTEN mutation
|
11 percentage of participants
|
11 percentage of participants
|
Adverse Events
Arm A - Irinotecan + KD018
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm B - Irinotecan + Placebo
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A - Irinotecan + KD018
n=16 participants at risk
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=15 participants at risk
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16
|
6.7%
1/15 • Number of events 4
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 7
|
0.00%
0/15
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 4
|
20.0%
3/15 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
General disorders
Fatigue
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Vascular disorders
Hypertension
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.8%
3/16 • Number of events 6
|
0.00%
0/15
|
|
Investigations
INR increased
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Investigations
Investigations - Other, specify
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Investigations
Lymphocyte count decreased
|
6.2%
1/16 • Number of events 4
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
18.8%
3/16 • Number of events 8
|
6.7%
1/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Psychiatric disorders
Suicidal ideation
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16
|
13.3%
2/15 • Number of events 3
|
|
Investigations
White blood cell decreased
|
12.5%
2/16 • Number of events 4
|
6.7%
1/15 • Number of events 2
|
Other adverse events
| Measure |
Arm A - Irinotecan + KD018
n=16 participants at risk
KD018: Traditional Chinese Medicine formulation administered orally twice a day for 4 days on days 1-4 every 2 weeks from the second cycle, at a dose of 1,800 mg, twice a day.
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
|
Arm B - Irinotecan + Placebo
n=15 participants at risk
Irinotecan: Irinotecan will be administered intravenously once every 2 weeks from the first cycle, at a dose of 215 mg/m².
Placebo: Placebo capsules will be administered orally twice a day for 4 days on days 1-4 every 2 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 2
|
13.3%
2/15 • Number of events 12
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16 • Number of events 14
|
20.0%
3/15 • Number of events 20
|
|
Investigations
Alkaline phosphatase increased
|
18.8%
3/16 • Number of events 8
|
26.7%
4/15 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
8/16 • Number of events 20
|
33.3%
5/15 • Number of events 16
|
|
Blood and lymphatic system disorders
Anemia
|
37.5%
6/16 • Number of events 36
|
46.7%
7/15 • Number of events 48
|
|
Metabolism and nutrition disorders
Anorexia
|
6.2%
1/16 • Number of events 4
|
20.0%
3/15 • Number of events 9
|
|
Psychiatric disorders
Anxiety
|
18.8%
3/16 • Number of events 6
|
13.3%
2/15 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
4/16 • Number of events 14
|
33.3%
5/15 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 8
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 4
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
6.2%
1/16 • Number of events 11
|
13.3%
2/15 • Number of events 4
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Cardiac disorders
Chest pain - cardiac
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
General disorders
Chills
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
18.8%
3/16 • Number of events 12
|
33.3%
5/15 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 4
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Creatinine increased
|
6.2%
1/16 • Number of events 4
|
20.0%
3/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Psychiatric disorders
Depression
|
12.5%
2/16 • Number of events 4
|
13.3%
2/15 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
62.5%
10/16 • Number of events 70
|
66.7%
10/15 • Number of events 77
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16
|
13.3%
2/15 • Number of events 4
|
|
Nervous system disorders
Dysarthria
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Nervous system disorders
Dysgeusia
|
6.2%
1/16 • Number of events 2
|
13.3%
2/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
4/16 • Number of events 8
|
6.7%
1/15 • Number of events 2
|
|
General disorders
Edema limbs
|
12.5%
2/16 • Number of events 4
|
0.00%
0/15
|
|
General disorders
Edema trunk
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Eye disorders
Eye disorders - Other, specify
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
General disorders
Fatigue
|
68.8%
11/16 • Number of events 36
|
60.0%
9/15 • Number of events 23
|
|
Gastrointestinal disorders
Fecal incontinence
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
General disorders
Fever
|
12.5%
2/16 • Number of events 4
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Flatulence
|
18.8%
3/16 • Number of events 12
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
2/16 • Number of events 4
|
0.00%
0/15
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
31.2%
5/16 • Number of events 34
|
26.7%
4/15 • Number of events 10
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
31.2%
5/16 • Number of events 10
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 4
|
|
Psychiatric disorders
Hallucinations
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Nervous system disorders
Headache
|
12.5%
2/16 • Number of events 4
|
13.3%
2/15 • Number of events 4
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
2/16 • Number of events 18
|
6.7%
1/15 • Number of events 2
|
|
Vascular disorders
Hot flashes
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
31.2%
5/16 • Number of events 16
|
13.3%
2/15 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
18.8%
3/16 • Number of events 6
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/16
|
13.3%
2/15 • Number of events 4
|
|
Vascular disorders
Hypertension
|
12.5%
2/16 • Number of events 4
|
6.7%
1/15 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
12.5%
2/16 • Number of events 4
|
13.3%
2/15 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
43.8%
7/16 • Number of events 26
|
33.3%
5/15 • Number of events 28
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
2/16 • Number of events 18
|
26.7%
4/15 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
12.5%
2/16 • Number of events 3
|
6.7%
1/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
4/16 • Number of events 8
|
20.0%
3/15 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
31.2%
5/16 • Number of events 26
|
26.7%
4/15 • Number of events 10
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 4
|
26.7%
4/15 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
37.5%
6/16 • Number of events 36
|
0.00%
0/15
|
|
Vascular disorders
Hypotension
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Investigations
INR increased
|
12.5%
2/16 • Number of events 6
|
0.00%
0/15
|
|
Immune system disorders
Immune system disorders - Other, specify
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Investigations - Other, specify
|
12.5%
2/16 • Number of events 6
|
6.7%
1/15 • Number of events 4
|
|
General disorders
Localized edema
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Investigations
Lymphocyte count decreased
|
37.5%
6/16 • Number of events 62
|
6.7%
1/15 • Number of events 6
|
|
Investigations
Lymphocyte count increased
|
12.5%
2/16 • Number of events 6
|
0.00%
0/15
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.2%
1/16 • Number of events 4
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
68.8%
11/16 • Number of events 42
|
46.7%
7/15 • Number of events 39
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
12.5%
2/16 • Number of events 8
|
6.7%
1/15 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
50.0%
8/16 • Number of events 48
|
46.7%
7/15 • Number of events 22
|
|
General disorders
Pain
|
25.0%
4/16 • Number of events 14
|
13.3%
2/15 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Nervous system disorders
Paresthesia
|
12.5%
2/16 • Number of events 4
|
0.00%
0/15
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.2%
1/16 • Number of events 4
|
6.7%
1/15 • Number of events 1
|
|
Investigations
Platelet count decreased
|
12.5%
2/16 • Number of events 6
|
0.00%
0/15
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.2%
1/16 • Number of events 4
|
0.00%
0/15
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/16
|
6.7%
1/15 • Number of events 4
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/16
|
13.3%
2/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
25.0%
4/16 • Number of events 10
|
13.3%
2/15 • Number of events 4
|
|
Psychiatric disorders
Restlessness
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Infections and infestations
Scrotal infection
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/16
|
6.7%
1/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Cardiac disorders
Sinus tachycardia
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
18.8%
3/16 • Number of events 6
|
6.7%
1/15 • Number of events 2
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/16
|
6.7%
1/15 • Number of events 2
|
|
Psychiatric disorders
Suicidal ideation
|
6.2%
1/16 • Number of events 2
|
0.00%
0/15
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
4/16 • Number of events 12
|
46.7%
7/15 • Number of events 27
|
|
Investigations
Weight loss
|
18.8%
3/16 • Number of events 8
|
13.3%
2/15 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 2
|
6.7%
1/15 • Number of events 2
|
|
Investigations
White blood cell decreased
|
62.5%
10/16 • Number of events 72
|
33.3%
5/15 • Number of events 26
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place