Trial Outcomes & Findings for Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase (NCT NCT03531320)

NCT ID: NCT03531320

Last Updated: 2023-11-24

Results Overview

MTD will be defined based on the number of dose limiting toxicities (DLT) in subjects at each dose level. DLT definition: In Part 1 of the study, any of the following AEs occurring during Cycle 1 will be classified as DLTs, if there is a reasonable possibility that it is related to the study drug * Hematologic: * Grade 4 neutropenia lasting \>7 days * Febrile neutropenia (defined as neutropenia Grade ≥3 and a body temp ≥38.3°C) * Grade ≥3 neutropenic infection * Grade 4 anemia * Grade ≥3 thrombocytopenia with bleeding * Grade 4 thrombocytopenia * Non-hematologic: o Grade ≥3 toxicities that are considered clinically significant, except those that have not been maximally treated (e.g., nausea, vomiting, diarrhea\*) or can be easily treated (e.g., electrolyte abnormalities). * Failure to deliver at least 6 of the planned 9 doses during Cycle 1 due to treatment-related toxicities. * Upon the second occurrence of a toxicity leading to a dose hold.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 19 participants
• Primary outcome timeframe: During Cycle 1 of treatment (each cycle is 21 days) for each subject
• Results posted on: 2023-11-24

Participant Flow

Participant milestones

Measure	Part 1:Dose-Escalation Phase_40mg 40 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase_60mg 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase_80mg 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase_120mg 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase_100mg 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride Due to safety concern, SMC members recommended adding a 100mg dose group instead of the 160mg dose.
Overall Study STARTED	4	3	3	6	3
Overall Study COMPLETED	3	3	3	6	3
Overall Study NOT COMPLETED	1	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase

Baseline characteristics by cohort

Measure	Part 1:Dose-Escalation Phase Level 1 n=4 Participants Cohort 1: 40 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 2 n=3 Participants Cohort 2: 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 3 n=3 Participants Cohort 3: 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 4 n=6 Participants Cohort 4: 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 5 n=3 Participants Cohort 5: 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Total n=19 Participants Total of all reporting groups
Age, Continuous	67.8 years STANDARD_DEVIATION 13.52 • n=5 Participants	57.7 years STANDARD_DEVIATION 10.69 • n=7 Participants	54.7 years STANDARD_DEVIATION 13.01 • n=5 Participants	55.5 years STANDARD_DEVIATION 10.88 • n=4 Participants	55.7 years STANDARD_DEVIATION 15.50 • n=21 Participants	58.3 years STANDARD_DEVIATION 12.14 • n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	15 Participants n=8 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	19 Participants n=8 Participants
Region of Enrollment Taiwan	4 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants	3 participants n=21 Participants	19 participants n=8 Participants

PRIMARY outcome

Timeframe: During Cycle 1 of treatment (each cycle is 21 days) for each subject

Population: Only Part 1 was conducted. 2 DLTs were happened in 120mg group, so the MTD is 100mg.

MTD will be defined based on the number of dose limiting toxicities (DLT) in subjects at each dose level.

DLT definition: In Part 1 of the study, any of the following AEs occurring during Cycle 1 will be classified as DLTs, if there is a reasonable possibility that it is related to the study drug

• Hematologic:

• Grade 4 neutropenia lasting >7 days
• Febrile neutropenia (defined as neutropenia Grade ≥3 and a body temp ≥38.3°C)
• Grade ≥3 neutropenic infection
• Grade 4 anemia
• Grade ≥3 thrombocytopenia with bleeding
• Grade 4 thrombocytopenia
• Non-hematologic:

o Grade ≥3 toxicities that are considered clinically significant, except those that have not been maximally treated (e.g., nausea, vomiting, diarrhea*) or can be easily treated (e.g., electrolyte abnormalities).

• Failure to deliver at least 6 of the planned 9 doses during Cycle 1 due to treatment-related toxicities.
• Upon the second occurrence of a toxicity leading to a dose hold.

Outcome measures

Measure	Part 1:Dose-Escalation Phase n=19 Participants 40 mg D07001-softgel capsules 60 mg D07001-softgel capsules 80 mg D07001-softgel capsules 120 mg D07001-softgel capsules 100 mg D07001-softgel capsules (additional cohort) D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 2 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 3 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 4 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 5 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride
Part 1: Establish the Maximum Tolerated Dose (MTD)	100 mg	—	—	—	—

PRIMARY outcome

Timeframe: From date of informed consent to 30-day follow-up visit for each subject, an average of 10 months

Population: Please refer to the Adverse Event tables for specifics.

AEs will be assessed via the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Outcome measures

Measure	Part 1:Dose-Escalation Phase n=4 Participants 40 mg D07001-softgel capsules 60 mg D07001-softgel capsules 80 mg D07001-softgel capsules 120 mg D07001-softgel capsules 100 mg D07001-softgel capsules (additional cohort) D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 2 n=3 Participants 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 3 n=3 Participants 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 4 n=6 Participants 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 5 n=3 Participants 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride
Part 1 : Incidence of Adverse Events (AEs)/ Serious Adverse Event (SAEs) Related to study drug SAEs	0 participants	0 participants	0 participants	2 participants	1 participants
Part 1 : Incidence of Adverse Events (AEs)/ Serious Adverse Event (SAEs) Related to study drug AEs	2 participants	2 participants	3 participants	6 participants	3 participants
Part 1 : Incidence of Adverse Events (AEs)/ Serious Adverse Event (SAEs) DLTs	0 participants	0 participants	0 participants	2 participants	0 participants

PRIMARY outcome

Timeframe: First dose through last dose for each subject, an average of 8 months

Population: Only Part 1 was conducted.

To measure ratio of total subjects who experienced the dose modifications including dose reduction, interruption, or discontinuation of study drug due to AEs.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 15

Population: Only Part 1 was conducted.

PK would be analyzed by maximum concentration (Cmax) of dFdC

Outcome measures

Measure	Part 1:Dose-Escalation Phase n=4 Participants 40 mg D07001-softgel capsules 60 mg D07001-softgel capsules 80 mg D07001-softgel capsules 120 mg D07001-softgel capsules 100 mg D07001-softgel capsules (additional cohort) D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 2 n=3 Participants 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 3 n=3 Participants 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 4 n=4 Participants 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 5 n=3 Participants 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride
Part 1: Pharmacokinetics (PK)- Cmax Cycle 1 Day 1	13.67 ng/mL Standard Deviation 7.58	42.97 ng/mL Standard Deviation 27.14	7.37 ng/mL Standard Deviation 5.68	37.24 ng/mL Standard Deviation 23.84	24.05 ng/mL Standard Deviation 17.43
Part 1: Pharmacokinetics (PK)- Cmax Cycle 1 Day 15	14.45 ng/mL Standard Deviation 13.93	12.93 ng/mL Standard Deviation 2.84	10.66 ng/mL Standard Deviation 9.15	18.47 ng/mL Standard Deviation 13.31	13.28 ng/mL Standard Deviation 7.92

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 15

Population: Only Part 1 was conducted.

PK would be analyzed by Area Under Curve (AUC) of dFdC

Outcome measures

Measure	Part 1:Dose-Escalation Phase n=4 Participants 40 mg D07001-softgel capsules 60 mg D07001-softgel capsules 80 mg D07001-softgel capsules 120 mg D07001-softgel capsules 100 mg D07001-softgel capsules (additional cohort) D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 2 n=3 Participants 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 3 n=3 Participants 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 4 n=4 Participants 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 5 n=3 Participants 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride
Part 1: PK- AUC Cycle 1 Day 1	12.35 h*ng/mL Standard Deviation 7.12	41.14 h*ng/mL Standard Deviation 4.42	11.59 h*ng/mL Standard Deviation 8.83	62.79 h*ng/mL Standard Deviation 42.10	54.40 h*ng/mL Standard Deviation 44.19
Part 1: PK- AUC Cycle 1 Day 15	12.71 h*ng/mL Standard Deviation 13.07	19.50 h*ng/mL Standard Deviation 3.74	14.05 h*ng/mL Standard Deviation 10.30	35.20 h*ng/mL Standard Deviation 33.29	36.96 h*ng/mL Standard Deviation 31.35

SECONDARY outcome

Timeframe: Cycle 1 Days 1, 8, and 15; Cycle 1 Day 15 and Cycle 2 Day 1 for food-effect cohort only

Population: Only Part 1 was conducted.

PK would be analyzed by maximum concentration (Cmax) of dFdC

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Days 1, 8, and 15; Cycle 1 Day 15 and Cycle 2 Day 1 for food-effect cohort only

Population: Only Part 1 was conducted.

PK would be analyzed by Area Under Curve (AUC) of dFdC

Outcome measures

Outcome data not reported

Adverse Events

Part 1:Dose-Escalation Phase Level 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1:Dose-Escalation Phase Level 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1:Dose-Escalation Phase Level 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1:Dose-Escalation Phase Level 4

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1:Dose-Escalation Phase Level 5

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Dose-Expansion Phase (Phase 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1:Dose-Escalation Phase Level 1 n=4 participants at risk 40 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 2 n=3 participants at risk 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 3 n=3 participants at risk 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 4 n=6 participants at risk 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 5 n=3 participants at risk 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 2: Dose-Expansion Phase (Phase 2) higher dose-expansion of D07001-softgel capsules lower dose-expansion of D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/6 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Hepatobiliary disorders hepatotoxicity	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	16.7% 1/6 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
General disorders Fever	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	16.7% 1/6 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.

Other adverse events

Measure	Part 1:Dose-Escalation Phase Level 1 n=4 participants at risk 40 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 2 n=3 participants at risk 60 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 3 n=3 participants at risk 80 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 4 n=6 participants at risk 120 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 1:Dose-Escalation Phase Level 5 n=3 participants at risk 100 mg D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride	Part 2: Dose-Expansion Phase (Phase 2) higher dose-expansion of D07001-softgel capsules lower dose-expansion of D07001-softgel capsules D07001-softgel capsules: Active Ingredient:Gemcitabine hydrochloride
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	50.0% 3/6 • Number of events 7 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	66.7% 2/3 • Number of events 5 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Gastrointestinal disorders Vomiting	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	66.7% 4/6 • Number of events 9 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
General disorders Fever	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 2/6 • Number of events 3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 2/6 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 2/6 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
General disorders Faitigue	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	66.7% 2/3 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	66.7% 4/6 • Number of events 4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
General disorders Chills	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 2/6 • Number of events 3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
General disorders Malaise	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 1/3 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	16.7% 1/6 • Number of events 1 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Investigations Alanine aminotransferase increased	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 2/6 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 2/6 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.
Nervous system disorders Somnolence	0.00% 0/4 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	33.3% 2/6 • Number of events 2 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	0.00% 0/3 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.	— 0/0 • The Adverse event information was collected and assessed in relation to baseline for study patients from the first dose of treatment until 30 days after discontinuation of treatment. Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 The AEs/SAEs were collected in relation to study drug.

Additional Information

Staff of Medical Affairs

InnoPharmax Inc.

Phone: 886-2-8797-7607

Email: yuan.lin@innopharmax.com

Results disclosure agreements

• Principal investigator is a sponsor employee There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
• Publication restrictions are in place

Restriction type: OTHER