Trial Outcomes & Findings for A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors (NCT NCT05093322)

Last Updated: 2024-06-07

Results Overview

A DLT was defined as any of following events that were attributable to study treatment (at least possibly related). Adverse events (AE) were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. * Any Grade 3 or greater nonhematological toxicity. * Grade 3 liver enzyme elevation. * Cases of Hy's law. * Any Grade 2 nonhematological toxicity that persisted for \>= 7 days. * Any Grade 4 hypertension. * Grade 3 corrected QT interval prolongation \> 500 millisecond. * Grade 4 thrombocytopenia for \> 7 days. * Grade 3 thrombocytopenia with clinically significant bleeding. * Grade 4 neutropenia that lasted for \> 7 days. * Myelosuppression that caused a delay of \> 7 days in the start of Cycle 2.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

From the first dose of study drug (Day 1) up to Day 35 of Cycle 1

Results posted on

2024-06-07

Participant Flow

This Phase 1/2 open-label study was conducted in pediatric, adolescent, and young adult patients with recurrent or refractory solid tumors at 8 study sites.

This study consisted of a screening period (up to 28 days), followed by a treatment phase (Cycle 1: 35 days and subsequent cycles: 21 days) and safety follow-up period (up to 30 days). A total of 13 patients were enrolled in this study. The planned expansion phase for this study was not opened.

Participant milestones

Participant milestones
Measure	Dose Level 1 Patients received surufatinib 120 milligram/meter square (mg/m\^2) oral capsule once daily (QD) as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose intravenous (IV) infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until progressive disease (PD), unacceptable toxicity, or death; whichever came first.	Dose Level 2 Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Overall Study STARTED	10	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 Patients received surufatinib 120 milligram/meter square (mg/m\^2) oral capsule once daily (QD) as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose intravenous (IV) infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until progressive disease (PD), unacceptable toxicity, or death; whichever came first.	Dose Level 2 Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Overall Study Death	6	2
Overall Study Other	4	1

Baseline Characteristics

A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Total n=13 Participants Total of all reporting groups
Age, Continuous	11.8 years STANDARD_DEVIATION 5.55 • n=93 Participants	13.7 years STANDARD_DEVIATION 2.89 • n=4 Participants	12.2 years STANDARD_DEVIATION 5.02 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	2 Participants n=4 Participants	8 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	9 Participants n=93 Participants	1 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized White	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to Day 35 of Cycle 1

Population: The DLT evaluable set included all patients enrolled in dose escalation phase of study who received at least 80% of surufatinib dose and both doses of gemcitabine during DLT evaluation period or who discontinued treatment due to a DLT.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=8 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Number of Patients With Dose-Limiting Toxicities (DLT)	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

The AEs were graded using the NCI CTCAE version 5.0. The CTCAE displays Grades 1 through 5 where, Grade 1= mild, Grade 2= moderate, Grade 3= Severe, Grade 4= life-threatening consequences and Grade 5= death.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity Grade 1	0 Participants	0 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity Grade 2	1 Participants	1 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity Grade 3	4 Participants	2 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity Grade 4	3 Participants	0 Participants
Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity Grade 5	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

Physical examination included patient height, weight, and general condition, as well as an examination of the head, heart, chest (including the lungs), abdomen, extremities, skin, lymph nodes, nervous system, and additional areas/systems as clinically indicated.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Number of Patients With Clinically Significant Physical Examination Abnormalities	6 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

Vital signs included systolic blood pressure (BP), diastolic BP, heart rate, height, weight, respiratory rate, and body temperature.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Number of Patients With Clinically Significant Vital Signs Abnormalities	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

Blood and urine samples were collected to determine the clinical chemistry, hematology, and urinalysis laboratory abnormalities.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Number of Patients With Clinically Significant Laboratory Abnormalities	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

Standard 12-lead ECGs were performed after the patient rested for 5 to 10 minutes. The ECG parameters included heart rate, PR interval, RR interval, QT interval, QTcF, and QRS interval from the triplicate 12-lead ECG.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Number of Patients With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities	1 Participants	0 Participants

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks.

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

The ORR was defined as the percentage of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST version 1.1 progression, death, or withdrawal of consent. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Objective Response Rate (ORR)	0 percentage of patients Interval 0.0 to 30.8	0 percentage of patients Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks.

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

The DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease as determined by the investigator using RECIST version 1.1. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Disease Control Rate (DCR)	20.0 percentage of patients Interval 2.5 to 55.6	0 percentage of patients Interval 0.0 to 70.8

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks.

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. No responders in this study.

The TTR was defined as the time from the start of study treatment until the date of the first occurrence of PR or CR for responders only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks.

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. No responders in this study.

The DoR was defined as the time from the first occurrence of PR or CR whichever came first, until disease progression or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks.

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

The PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST version 1.1 or death from any cause.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=10 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 Participants Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Progression-Free Survival (PFS)	1.8 months Interval 0.7 to The upper limit of 95% confidence interval could not be estimated either due to insufficient number of PFS events or not sufficient follow-up time at the time of the analysis.	1.5 months Interval 1.1 to The upper limit of 95% confidence interval could not be estimated either due to insufficient number of PFS events or not sufficient follow-up time at the time of the analysis.

SECONDARY outcome

Timeframe: Days 1 and 8 of Cycle 1

Population: The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. Only patients who performed the survey are reported.

The taste and palatability survey was assessed in patients who had taken surufatinib oral suspension. For pediatric patients, their parents completed the taste and palatability survey. Data for the evaluation of taste of surufatinib oral suspension was summarized on a scale of 1 (very bad) through 5 (very nice).

Outcome measures

Outcome measures
Measure	Dose Level 1 n=2 Participants Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 1: Very Nice	0 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 1: Nice	1 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 1: Not Nice, not Bad	0 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 1: Bad	1 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 1: Very Bad	0 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 8: Very Nice	0 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 8: Nice	1 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 8: Not Nice, not Bad	0 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 8: Bad	1 Participants	—
Number of Patients Who Performed Taste and Palatability Survey of Surufatinib Cycle 1 Day 8: Very Bad	0 Participants	—

Adverse Events

Dose Level 1

Serious events: 7 serious events

Other events: 10 other events

Deaths: 6 deaths

Dose Level 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 n=10 participants at risk Patients received surufatinib 120 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.	Dose Level 2 n=3 participants at risk Patients received surufatinib 160 mg/m\^2 oral capsule QD as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine 1000 mg/m\^2/dose IV infusion on Days 15 and 22 of a 35-day Cycle 1 and on Days 1 and 8 of 21-day subsequent cycles until PD, unacceptable toxicity, or death; whichever came first.
Nervous system disorders Spinal cord compression	10.0% 1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
General disorders Pyrexia	30.0% 3/10 • Number of events 3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
General disorders Disease progression	20.0% 2/10 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 2/10 • Number of events 2 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	33.3% 1/3 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/10 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	33.3% 1/3 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/10 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	33.3% 1/3 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Respiratory, thoracic and mediastinal disorders Respiratory failure	10.0% 1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Infections and infestations Respiratory tract infection viral	10.0% 1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Product Issues Device breakage	10.0% 1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Metabolism and nutrition disorders Dehydration	10.0% 1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
Metabolism and nutrition disorders Hypokalaemia	10.0% 1/10 • Number of events 1 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.	0.00% 0/3 • Treatment-emergent AEs (TEAEs) were collected from the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.

Other adverse events

Additional Information

Nick Lawn

HUTCHMED Limited

Phone: +44 7826 422448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place