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

• ClinicalTrials.gov Identifier: NCT00730158
• Recruitment Status: Completed
• First Posted: August 8, 2008
• Results First Posted: May 22, 2019
• Last Update Posted: May 22, 2019
• Sponsor: Edward Chu, MD
• Collaborator: Kadmon Corporation, LLC
• Information provided by (Responsible Party): Edward Chu, MD, University of Pittsburgh

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Neoplasms
• Interventions: Drug: KD018; Drug: Irinotecan; Drug: Placebo
• Enrollment: 33

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Irinotecan+ KD018	Irinotecan + Placebo
Arm/Group Description	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: 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.
Period Title: Overall Study
Started	17	16
Completed	16	15
Not Completed	1	1
Reason Not Completed
Withdrawal by Subject	1	1

Baseline Characteristics

Arm/Group Title		Irinotecan+ KD018	Irinotecan + Placebo	Total
Arm/Group Description		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: 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 of all reporting groups
Overall Number of Baseline Participants		16	15	31
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	16 participants	15 participants	31 participants
		65.6 (12.4)	57.6 (12.7)	61.7 (13.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	16 participants	15 participants	31 participants
	Female	6 37.5%	7 46.7%	13 41.9%
	Male	10 62.5%	8 53.3%	18 58.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	16 participants	15 participants	31 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 6.3%	1 6.7%	2 6.5%
	White	14 87.5%	14 93.3%	28 90.3%
	More than one race	1 6.3%	0 0.0%	1 3.2%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With Grade 2-4 Toxicities
Description	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.
Time Frame	Up to 3 months after start of study treatment

Outcome Measure Data

Analysis Population Description

Participants that received at least 3 months of study treatment.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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 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 Number of Participants Analyzed	16	15
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: proportion of participants
	0.63; (0.35 to 0.85)	0.40; (0.16 to 0.68)

2. Secondary Outcome

Title	Overall Response (OR)
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants evaluable for response.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	12
Measure Type: Number; Unit of Measure: participants
	7	10

3. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	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).
Time Frame	Up to 450 days

Outcome Measure Data

Analysis Population Description

Patients that were evaluable for response and survival data were obtainable.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	12	14
Median (95% Confidence Interval); Unit of Measure: Days
	122 [1]; (106 to NA)	104; (52 to 242)

[1]

Statistically Not Reached.

4. Secondary Outcome

Title	Overall Survival (OS)
Description	Median number of days from the start of treatment that study participants remained alive.
Time Frame	Up to 900 days

Outcome Measure Data

Analysis Population Description

All participants.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	16	15
Median (95% Confidence Interval); Unit of Measure: Days
	291 [1]; (174 to NA)	482 [1]; (308 to NA)

[1]

Statistically Not Reached

5. Secondary Outcome

Title	Clinical Response (CR)
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Participants that were evaluable for response.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	12
Measure Type: Number; Unit of Measure: participants
Progressed Disease	7	2
Stable Disease	5	9
Partial Response	2	1

6. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy (Diarrhea) FACIT-D Total Score
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	12	13
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	40.09; (36.02 to 44.16)	39.77; (36.98 to 42.56)
Cycle 1	37.66; (34.37 to 40.95)	35.55; (30.98 to 40.12)
Cycle 2	34.78; (28.57 to 40.98)	37.78; (33.09 to 42.47)
Cycle 3	37.75; (32.64 to 42.86)	35.65; (29.48 to 41.82)
Cycle 4	35.62; (30.10 to 41.15)	35.71; (29.89 to 41.53)
Cycle 5	37.09; (29.93 to 44.24)	31.25; (25.53 to 36.97)
Cycle 6	36.54; (29.52 to 43.57)	30.38; (19.30 to 41.47)
Cycle 7	38.60; (31.49 to 45.71)	29.33; (19.06 to 39.61)
Cycle 8	38.50; (23.10 to 53.90)	28.20; (18.14 to 38.26)
Cycle 9	35.67; (16.69 to 54.64)	32.50; (0.73 to 64.27)
Cycle 10	30.00; (4.59 to 55.41)	31.50; (-25.68 to 88.68)

7. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy FACIT-D - PWB: Physical Well-Being
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	14
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	23.18; (21.09 to 25.27)	21.79; (18.14 to 25.43)
Cycle 1	21.69; (17.70 to 25.68)	22.00; (18.64 to 25.36)
Cycle 2	22.00; (18.27 to 25.73)	22.21; (18.64 to 25.78)
Cycle 3	24.26; (22.40 to 26.12)	21.30; (17.18 to 25.42)
Cycle 4	22.67; (20.12 to 25.22)	23.09; (20.62 to 25.56)
Cycle 5	23.62; (20.95 to 26.30)	21.88; (17.08 to 26.67)
Cycle 6	23.50; (21.09 to 25.91)	20.00; (14.37 to 25.22)
Cycle 7	22.14; (19.67 to 24.61)	20.83; (16.31 to 25.36)
Cycle 8	22.67; (19.37 to 25.96)	17.40; (11.81 to 22.99)
Cycle 9	22.00; (15.64 to 28.36)	22.50; (-9.27 to 54.27)
Cycle 10	23.33; (10.83 to 35.84)	23.50; (17.15 to 29.85)

8. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy FACIT-D EWB: Emotional Well-Being
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle (every 2 weeks).

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	14
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	19.85; (17.87 to 21.82)	16.43; (13.48 to 19.38)
Cycle 1	18.00; (15.19 to 20.81)	16.43; (13.33 to 19.53)
Cycle 2	19.96; (17.36 to 22.55)	17.30; (14.06 to 20.54)
Cycle 3	20.11; (17.52 to 22.70)	17.76; (14.11 to 21.41)
Cycle 4	19.33; (16.76 to 21.91)	19.55; (17.39 to 21.70)
Cycle 5	20.38; (17.81 to 22.94)	18.75; (15.22 to 22.28)
Cycle 6	19.88; (17.53 to 22.22)	17.20; (11.35 to 23.05)
Cycle 7	20.57; (18.25 to 22.89)	17.80; (12.95 to 22.65)
Cycle 8	20.33; (17.88 to 22.79)	15.50; (6.00 to 25.00)
Cycle 9	21.25; (16.87 to 25.63)	21.00; (-4.41 to 46.41)
Cycle 10	22.00; (17.03 to 26.97)	20.30; (3.78 to 36.82)

9. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy FACIT-D SWB: Social Well-Being
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	14
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	25.85; (24.74 to 26.96)	23.91; (20.52 to 27.29)
Cycle 1	21.46; (17.01 to 25.92)	24.33; (21.30 to 27.36)
Cycle 2	20.74; (14.07 to 27.41)	25.60; (23.70 to 27.50)
Cycle 3	25.09; (22.16 to 28.03)	25.33; (23.74 to 26.91)
Cycle 4	23.43; (20.17 to 26.68)	24.60; (21.23 to 27.97)
Cycle 5	25.07; (21.71 to 28.44)	24.29; (19.09 to 29.49)
Cycle 6	22.19; (15.33 to 29.04)	23.60; (21.90 to 24.21)
Cycle 7	25.83; (21.76 to 29.91)	22.89; (19.05 to 26.73)
Cycle 8	24.22; (19.58 to 28.87)	21.63; (15.45 to 27.82)
Cycle 9	25.67; (20.42 to 30.92)	23.00; (-2.41 to 48.41)
Cycle 10	24.94; (14.21 to 35.68)	23.50; (-8.27 to 55.27)

10. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy FACIT-D FWB: Functional Well-Being
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	14
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	19.85; (16.48 to 23.21)	18.07; (14.44 to 21.70)
Cycle 1	18.89; (14.62 to 23.17)	17.21; (13.84 to 20.59)
Cycle 2	19.78; (15.43 to 24.97)	20.20; (14.46 to 25.10)
Cycle 3	20.11; (15.59 to 24.63)	19.32; (14.33 to 24.30)
Cycle 4	19.44; (15.47 to 23.42)	19.09; (14.86 to 23.32)
Cycle 5	19.77; (16.09 to 23.46)	20.50; (10.56 to 30.44)
Cycle 6	19.62; (15.48 to 23.77)	17.00; (10.31 to 23.69)
Cycle 7	19.00; (12.98 to 25.02)	16.40; (10.74 to 22.06)
Cycle 8	19.83; (14.85 to 24.82)	17.00; (7.19 to 26.81)
Cycle 9	22.58; (7.19 to 26.81)	20.50; (14.85 to 24.82)
Cycle 10	21.00; (-35.68 to 78.68)	21.50; (2.25 to 39.75)

11. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy FACIT-D FACTG: FACT-G Total Score (PWB+SWB+EWB+FWB)
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACT-G during any single treatment cycle.

Arm/Group Title	Arm A - Irinotecan+ KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	13	14
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	88.72; (82.18 to 95.26)	80.19; (68.66 to 91.73)
Cycle 1	80.05; (68.46 to 91.64)	79.98; (69.37 to 90.58)
Cycle 2	82.47; (69.52 to 95.42)	84.99; (72.48 to 97.51)
Cycle 3	89.57; (79.78 to 99.37)	83.70; (70.54 to 96.86)
Cycle 4	84.87; (75.61 to 94.13)	86.33; (76.32 to 96.33)
Cycle 5	88.85; (78.33 to 99.36)	85.42; (64.40 to 106.44)
Cycle 6	85.19; (73.99 to 96.38)	79.07; (65.44 to 92.70)
Cycle 7	87.55; (75.96 to 99.13)	76.43; (60.23 to 92.62)
Cycle 8	87.06; (74.44 to 99.67)	74.79; (48.58 to 101.00)
Cycle 9	91.50; (73.24 to 109.76)	87.00; (-65.47 to 239.47)
Cycle 10	91.28; (53.15 to 129.40)	88.80; (-23.01 to 200.61)

12. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy FACIT-Fatigue FS: Fatigue Score
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACT-Fatigue FS during any single treatment cycle.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	13	12
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	41.39; (36.50 to 46.28)	36.17; (28.42 to 43.91)
Cycle 1	36.09; (26.22 to 45.96)	36.67; (30.36 to 42.97)
Cycle 2	38.80; (32.68 to 44.92)	38.45; (30.44 to 46.47)
Cycle 3	41.67; (36.57 to 46.77)	36.22; (27.19 to 45.26)
Cycle 4	40.22; (36.18 to 44.27)	38.56; (30.64 to 46.47)
Cycle 5	40.25; (36.02 to 44.48)	39.75; (23.77 to 55.73)
Cycle 6	41.53; (36.03 to 47.03)	30.72; (20.11 to 41.33)
Cycle 7	41.33; (34.67 to 47.99)	33.33; (22.74 to 43.93)
Cycle 8	40.78; (28.92 to 52.65)	30.20; (14.96 to 45.44)
Cycle 9	40.25; (29.59 to 50.91)	33.33; (-1.47 to 68.14)
Cycle 10	41.50; (30.14 to 52.86)	40.00; (-36.24 to 116.24)

13. Secondary Outcome

Title	The Functional Assessment of Chronic Illness Therapy FACIT-D TOI: Trial Outcome Index
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Maximum number of participants that completed the FACIT-D during any single treatment cycle (every 2 weeks).

Arm/Group Title	Arm A - Irinotecan+ KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	13	12
Mean (95% Confidence Interval); Unit of Measure: score on a scale
Cycle 0	82.03; (75.36 to 88.70)	79.23; (71.42 to 87.04)
Cycle 1	78.01; (68.39 to 87.63)	75.17; (66.46 to 83.89)
Cycle 2	76.56; (62.84 to 90.27)	82.42; (72.85 to 91.98)
Cycle 3	81.88; (71.97 to 91.78)	76.27; (62.73 to 89.80)
Cycle 4	77.12; (68.15 to 86.10)	79.11; (67.99 to 90.23)
Cycle 5	80.40; (67.97 to 92.82)	73.62; (56.42 to 90.83)
Cycle 6	79.11; (68.09 to 90.14)	66.46; (47.02 to 85.90)
Cycle 7	82.00; (67.33 to 96.67)	65.40; (47.27 to 83.53)
Cycle 8	81.25; (55.74 to 106.76)	61.50; (33.62 to 89.38)
Cycle 9	80.44; (38.37 to 122.52)	75.50; (-57.92 to 208.92)
Cycle 10	68.50; (-1.38 to 138.38)	76.50; (-44.21 to 197.21)

14. Secondary Outcome

Title	Metabolites and Cytokine Scoring for Prediction of Time to Disease Progression
Description	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.
Time Frame	Up to 36 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	8	9
Measure Type: Number; Unit of Measure: participants
Scores < 4.8 (two metabolites)	3	3
Scores > 4.8 (two metabolites)	5	6
Scores < 4.8 (one metabolite+two cytokine)	2	4
Scores > 4.8 (one metabolite+two cytokine)	6	5

15. Secondary Outcome

Title	Uridine Diphosphate Glucuronosyltransferase (UGT) 1A1 Alleles
Description	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.
Time Frame	From 30 minutes prior to irinotecan infusion through to Immediately after irinotecan infusion, up to 8 weeks

Outcome Measure Data

Analysis Population Description

Patients who completed at least (3) treatment cycles.

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	12
Measure Type: Number; Unit of Measure: number of participants
genotype 5/6	0	1
genotype 6/6	4	4
genotype 6/7	5	4
genotype 7/7	0	0

16. Secondary Outcome

Title	Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Description	Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.
Time Frame	Baseline - prior to treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A - Irinotecan + KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	12
Measure Type: Number; Unit of Measure: percentage of participants
Braf mutation	22	22
Kras mutation	66	44
Nras mutation	11	0
PIK3CA mutation	22	55
PTEN mutation	11	11

17. Secondary Outcome

Title	Circulating Tumor DNA - Percentage of Patients With DNA Mutations
Description	Percentage of patients with Braf, Kras, Nras, PIK3CA and PTEN mutations associated with tumor detected in the circulating DNA of plasma, before treatment.
Time Frame	End of treatment - up to 8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A - Irinotecan+ KD018	Arm B - Irinotecan + Placebo
Arm/Group Description:	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: 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 Number of Participants Analyzed	14	12
Measure Type: Number; Unit of Measure: percentage of participants
Braf mutation	0	22
Kras mutation	33	44
Nras mutation	11	11
PIK3CA mutation	22	0
PTEN mutation	11	11

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Arm A - Irinotecan + KD018		Arm B - Irinotecan + Placebo
Arm/Group Description	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: 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.
All-Cause Mortality
	Arm A - Irinotecan + KD018		Arm B - Irinotecan + Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Arm A - Irinotecan + KD018		Arm B - Irinotecan + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/16 (18.75%)		4/15 (26.67%)
Blood and lymphatic system disorders
Anemia †	0/16 (0.00%)	0	1/15 (6.67%)	2
Cardiac disorders
Cardiac disorders - Other, specify †	1/16 (6.25%)	2	0/15 (0.00%)	0
Gastrointestinal disorders
Diarrhea †	1/16 (6.25%)	4	3/15 (20.00%)	5
Gastrointestinal disorders - Other, specify †	1/16 (6.25%)	2	0/15 (0.00%)	0
Nausea †	0/16 (0.00%)	0	1/15 (6.67%)	1
Vomiting †	0/16 (0.00%)	0	2/15 (13.33%)	3
General disorders
Fatigue †	1/16 (6.25%)	2	1/15 (6.67%)	2
Investigations
Alanine aminotransferase increased †	0/16 (0.00%)	0	1/15 (6.67%)	2
Alkaline phosphatase increased †	1/16 (6.25%)	2	0/15 (0.00%)	0
Aspartate aminotransferase increased †	0/16 (0.00%)	0	1/15 (6.67%)	2
Blood bilirubin increased †	1/16 (6.25%)	7	0/15 (0.00%)	0
INR increased †	1/16 (6.25%)	2	0/15 (0.00%)	0
Investigations - Other, specify †	1/16 (6.25%)	2	0/15 (0.00%)	0
Lymphocyte count decreased †	1/16 (6.25%)	4	0/15 (0.00%)	0
Neutrophil count decreased †	3/16 (18.75%)	8	1/15 (6.67%)	2
White blood cell decreased †	2/16 (12.50%)	4	1/15 (6.67%)	2
Metabolism and nutrition disorders
Hypermagnesemia †	1/16 (6.25%)	2	0/15 (0.00%)	0
Hypoalbuminemia †	1/16 (6.25%)	2	0/15 (0.00%)	0
Hypokalemia †	0/16 (0.00%)	0	1/15 (6.67%)	2
Hyponatremia †	0/16 (0.00%)	0	1/15 (6.67%)	2
Hypophosphatemia †	3/16 (18.75%)	6	0/15 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain †	0/16 (0.00%)	0	1/15 (6.67%)	4
Psychiatric disorders
Suicidal ideation †	1/16 (6.25%)	2	0/15 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnea †	1/16 (6.25%)	2	0/15 (0.00%)	0
Respiratory, thoracic and mediastinal disorders - Other, specify †	1/16 (6.25%)	2	0/15 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash maculo-papular †	1/16 (6.25%)	2	0/15 (0.00%)	0
Vascular disorders
Hypertension †	1/16 (6.25%)	2	0/15 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm A - Irinotecan + KD018		Arm B - Irinotecan + Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/16 (68.75%)		10/15 (66.67%)
Blood and lymphatic system disorders
Anemia †	6/16 (37.50%)	36	7/15 (46.67%)	48
Cardiac disorders
Cardiac disorders - Other, specify †	1/16 (6.25%)	2	0/15 (0.00%)	0
Chest pain - cardiac †	1/16 (6.25%)	2	0/15 (0.00%)	0
Sinus bradycardia †	0/16 (0.00%)	0	1/15 (6.67%)	4
Sinus tachycardia †	1/16 (6.25%)	2	1/15 (6.67%)	2
Eye disorders
Eye disorders - Other, specify †	1/16 (6.25%)	2	0/15 (0.00%)	0
Gastrointestinal disorders
Abdominal pain †	1/16 (6.25%)	2	2/15 (13.33%)	12
Bloating †	1/16 (6.25%)	4	1/15 (6.67%)	2
Colonic hemorrhage †	0/16 (0.00%)	0	1/15 (6.67%)	2
Constipation †	3/16 (18.75%)	12	5/15 (33.33%)	10
Diarrhea †	10/16 (62.50%)	70	10/15 (66.67%)	77
Dry mouth †	0/16 (0.00%)	0	2/15 (13.33%)	4
Fecal incontinence †	1/16 (6.25%)	2	1/15 (6.67%)	2
Flatulence †	3/16 (18.75%)	12	0/15 (0.00%)	0
Gastritis †	0/16 (0.00%)	0	1/15 (6.67%)	2
Gastroesophageal reflux disease †	2/16 (12.50%)	4	0/15 (0.00%)	0
Gastrointestinal disorders - Other, specify †	5/16 (31.25%)	34	4/15 (26.67%)	10
Hemorrhoids †	0/16 (0.00%)	0	1/15 (6.67%)	2
Mucositis oral †	0/16 (0.00%)	0	1/15 (6.67%)	2
Nausea †	11/16 (68.75%)	42	7/15 (46.67%)	39
Rectal hemorrhage †	0/16 (0.00%)	0	1/15 (6.67%)	4
Stomach pain †	0/16 (0.00%)	0	1/15 (6.67%)	2
Vomiting †	4/16 (25.00%)	12	7/15 (46.67%)	27
General disorders
Chills †	1/16 (6.25%)	2	0/15 (0.00%)	0
Edema limbs †	2/16 (12.50%)	4	0/15 (0.00%)	0
Edema trunk †	1/16 (6.25%)	2	0/15 (0.00%)	0
Fatigue †	11/16 (68.75%)	36	9/15 (60.00%)	23
Fever †	2/16 (12.50%)	4	1/15 (6.67%)	2
General disorders and administration site conditions - Other, specify †	5/16 (31.25%)	10	1/15 (6.67%)	2
Localized edema †	1/16 (6.25%)	2	0/15 (0.00%)	0
Pain †	4/16 (25.00%)	14	2/15 (13.33%)	10
Immune system disorders
Immune system disorders - Other, specify †	0/16 (0.00%)	0	1/15 (6.67%)	2
Infections and infestations
Scrotal infection †	1/16 (6.25%)	2	0/15 (0.00%)	0
Investigations
Alanine aminotransferase increased †	3/16 (18.75%)	14	3/15 (20.00%)	20
Alkaline phosphatase increased †	3/16 (18.75%)	8	4/15 (26.67%)	8
Aspartate aminotransferase increased †	4/16 (25.00%)	14	5/15 (33.33%)	20
Blood bilirubin increased †	1/16 (6.25%)	11	2/15 (13.33%)	4
Creatinine increased †	1/16 (6.25%)	4	3/15 (20.00%)	6
INR increased †	2/16 (12.50%)	6	0/15 (0.00%)	0
Investigations - Other, specify †	2/16 (12.50%)	6	1/15 (6.67%)	4
Lymphocyte count decreased †	6/16 (37.50%)	62	1/15 (6.67%)	6
Lymphocyte count increased †	2/16 (12.50%)	6	0/15 (0.00%)	0
Neutrophil count decreased †	8/16 (50.00%)	48	7/15 (46.67%)	22
Platelet count decreased †	2/16 (12.50%)	6	0/15 (0.00%)	0
Weight loss †	3/16 (18.75%)	8	2/15 (13.33%)	5
White blood cell decreased †	10/16 (62.50%)	72	5/15 (33.33%)	26
Metabolism and nutrition disorders
Anorexia †	1/16 (6.25%)	4	3/15 (20.00%)	9
Dehydration †	1/16 (6.25%)	2	1/15 (6.67%)	2
Hyperglycemia †	5/16 (31.25%)	16	2/15 (13.33%)	10
Hyperkalemia †	3/16 (18.75%)	6	0/15 (0.00%)	0
Hypermagnesemia †	1/16 (6.25%)	2	1/15 (6.67%)	2
Hypernatremia †	0/16 (0.00%)	0	2/15 (13.33%)	4
Hyperuricemia †	2/16 (12.50%)	4	2/15 (13.33%)	6
Hypoalbuminemia †	7/16 (43.75%)	26	5/15 (33.33%)	28
Hypocalcemia †	2/16 (12.50%)	18	4/15 (26.67%)	8
Hypoglycemia †	2/16 (12.50%)	3	1/15 (6.67%)	2
Hypokalemia †	4/16 (25.00%)	8	3/15 (20.00%)	14
Hypomagnesemia †	5/16 (31.25%)	26	4/15 (26.67%)	10
Hyponatremia †	1/16 (6.25%)	4	4/15 (26.67%)	16
Hypophosphatemia †	6/16 (37.50%)	36	0/15 (0.00%)	0
Metabolism and nutrition disorders - Other, specify †	0/16 (0.00%)	0	1/15 (6.67%)	2
Musculoskeletal and connective tissue disorders
Back pain †	1/16 (6.25%)	2	1/15 (6.67%)	8
Chest wall pain †	0/16 (0.00%)	0	1/15 (6.67%)	2
Generalized muscle weakness †	1/16 (6.25%)	2	1/15 (6.67%)	4
Musculoskeletal and connective tissue disorder - Other, specify †	1/16 (6.25%)	2	1/15 (6.67%)	2
Myalgia †	1/16 (6.25%)	4	0/15 (0.00%)	0
Pain in extremity †	1/16 (6.25%)	2	0/15 (0.00%)	0
Nervous system disorders
Dizziness †	1/16 (6.25%)	2	0/15 (0.00%)	0
Dysarthria †	1/16 (6.25%)	2	0/15 (0.00%)	0
Dysgeusia †	1/16 (6.25%)	2	2/15 (13.33%)	4
Headache †	2/16 (12.50%)	4	2/15 (13.33%)	4
Nervous system disorders - Other, specify †	2/16 (12.50%)	8	1/15 (6.67%)	2
Paresthesia †	2/16 (12.50%)	4	0/15 (0.00%)	0
Peripheral sensory neuropathy †	1/16 (6.25%)	4	1/15 (6.67%)	1
Psychiatric disorders
Anxiety †	3/16 (18.75%)	6	2/15 (13.33%)	4
Depression †	2/16 (12.50%)	4	2/15 (13.33%)	6
Hallucinations †	1/16 (6.25%)	2	0/15 (0.00%)	0
Insomnia †	1/16 (6.25%)	2	1/15 (6.67%)	2
Restlessness †	1/16 (6.25%)	2	0/15 (0.00%)	0
Suicidal ideation †	1/16 (6.25%)	2	0/15 (0.00%)	0
Renal and urinary disorders
Proteinuria †	0/16 (0.00%)	0	1/15 (6.67%)	2
Renal and urinary disorders - Other, specify †	0/16 (0.00%)	0	2/15 (13.33%)	4
Respiratory, thoracic and mediastinal disorders
Cough †	2/16 (12.50%)	4	1/15 (6.67%)	2
Dyspnea †	4/16 (25.00%)	8	1/15 (6.67%)	2
Hiccups †	2/16 (12.50%)	18	1/15 (6.67%)	2
Hypoxia †	1/16 (6.25%)	2	0/15 (0.00%)	0
Nasal congestion †	1/16 (6.25%)	2	1/15 (6.67%)	2
Respiratory, thoracic and mediastinal disorders - Other, specify †	4/16 (25.00%)	10	2/15 (13.33%)	4
Sinus disorder †	1/16 (6.25%)	2	0/15 (0.00%)	0
Wheezing †	1/16 (6.25%)	2	1/15 (6.67%)	2
Skin and subcutaneous tissue disorders
Alopecia †	8/16 (50.00%)	20	5/15 (33.33%)	16
Pruritus †	1/16 (6.25%)	2	0/15 (0.00%)	0
Rash maculo-papular †	1/16 (6.25%)	4	0/15 (0.00%)	0
Skin and subcutaneous tissue disorders - Other, specify †	3/16 (18.75%)	6	1/15 (6.67%)	2
Vascular disorders
Hot flashes †	1/16 (6.25%)	2	0/15 (0.00%)	0
Hypertension †	2/16 (12.50%)	4	1/15 (6.67%)	12
Hypotension †	1/16 (6.25%)	2	1/15 (6.67%)	2
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Edward Chu, MD
• Organization: UPMC Hillman Cancer Center
• Phone: (412) 648-6589
• EMail: chue2@upmc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lam W, Bussom S, Guan F, Jiang Z, Zhang W, Gullen EA, Liu SH, Cheng YC. The four-herb Chinese medicine PHY906 reduces chemotherapy-induced gastrointestinal toxicity. Sci Transl Med. 2010 Aug 18;2(45):45ra59. doi: 10.1126/scitranslmed.3001270.

• Responsible Party: Edward Chu, MD, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT00730158
• Other Study ID Numbers: 12-005; ACS IRG 58-012-49
• First Submitted: August 4, 2008
• First Posted: August 8, 2008
• Results First Submitted: August 15, 2018
• Results First Posted: May 22, 2019
• Last Update Posted: May 22, 2019