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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003602-41 | EudraCT Number |
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The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory solid tumors or lymphoma. The study will be conducted in 2 parts.
The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory solid tumors or lymphoma. The study will be conducted in 2 parts:
Part 1 - evaluation of tolerability and safety of surufatinib administered in combination with gemcitabine, and confirmation of the recommended clinical dose of surufatinib in pediatric patients with recurrent or refractory solid tumors or lymphoma.
Part 2 - evaluation of anti-tumor activity and confirmation of tolerability of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory osteosarcoma, Ewing sarcoma, RMS, and non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).
Part 1 will enroll 2 to 6 patients per dose level cohort (up to 4 cohorts) with recurrent or refractory solid tumors. During cycle 1, surufatinib will be administered, orally, once daily (QD), as a single agent for 14 days followed by surufatinib daily in combination with gemcitabine intravenously on days 15 and 22 (cycle 1 duration=35 days) and days 1 and 8 of all subsequent cycles (cycle duration=21 days). Assessment based on dose limiting toxicity (DLT) criteria will be performed in the first 35-day cycle (DLT Evaluation Period). This study will utilize a rolling 6 design for part 1, with 3 dose escalation levels and 1 de escalation level, if needed.
Part 2 of the study will use a Simon 2-stage design with a maximum of 18 patients per cohort (osteosarcoma, Ewing sarcoma, RMS, and non-rhabdomyosarcoma soft tissue sarcoma (NRSTS)).
Surufatinib will be administered orally at identified MTD/RP2D daily in combination with gemcitabine (1000 mg/m2 weekly × 2 doses) intravenously on days 1 and 8.
In both parts 1 and 2, patients can remain on treatment until completing cycle 17, or until progressive disease, unacceptable toxicity, or death; whichever comes first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1- Dose escalation | Experimental | Dose escalation study with sequential dose escalation of surufatinib in combination with gemcitabine. Patients with any recurrent or refractory solid tumors or lymphoma, who have a known or expected dysfunction of VEGFR-1, -2, and -3; FGFR-1; or CSF-1R pathways may be enrolled. |
|
| Part 2 - Dose expansion | Experimental | Once the MTD/RP2D has been determined in the part 1 portion of the study, the part 2 disease specific cohorts for patients with refractory or recurrent osteosarcoma, Ewing Sarcoma, and RMS and NRSTS will open for enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surufatinib in combination with Gemcitabine | Drug | Surufatinib in combination with Gemcitabine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Dose-Limiting Toxicities (DLT) | 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.
| From the first dose of study drug (Day 1) up to Day 35 of Cycle 1 |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | 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. | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| Number of Patients With Clinically Significant Physical Examination Abnormalities | 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. | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| Number of Patients With Clinically Significant Vital Signs Abnormalities | Vital signs included systolic blood pressure (BP), diastolic BP, heart rate, height, weight, respiratory rate, and body temperature. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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. |
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Inclusion Criteria:
Age: At time of study enrollment, patients must be
For US Sites:
For EU/UK Sites:
Part 1 (including PK expansion cohort): from birth to <18 years of age;
Part 2: from birth to <18 years of age (except as noted below);
Diagnosis:
Disease status: Patients must have measureable or evaluable disease for part 1 dose escalation; for part 2, patients must have measurable disease by RECIST version 1.1.
Therapeutic options: Patient's current disease state must be one for which there is no known curative therapy.
Performance level: Karnofsky ≥50 for patients ≥16 and <18 years of age and Lansky ≥50 for patients <16 years of age, Eastern Cooperative Oncology Group (ECOG) ≤2 for patients ≥18 years of age.
Adequate organ and bone marrow function as defined in the current protocol.
Adequate cardiac function as indicated as defined in the current protocol.
Patients with known bone marrow metastatic disease will be eligible for the study provided they meet the blood counts in the inclusion criteria as defined in the current protocol.
Adequate BP control which is defined as a BP <95th percentile (≤ grade 1) for age, height, and sex.
Informed consent: Provision of signed and dated written informed consent (parent/legal guardian if patient <18 years of age) and assent (from patients aged >7 years) prior to any study-specific procedures, sampling, and analyses.
Patient must meet all defined Inclusion criteria as defined in the current protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josephine Haduong | Children's Hospital of Orange County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| Childrens Hospital Orange County |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2023 | Apr 18, 2024 |
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The study will be conducted in 2 parts:
Part 1 - evaluation of tolerability and safety of surufatinib administered in combination with gemcitabine, and confirmation of the recommended clinical dose of surufatinib in pediatric patients with recurrent or refractory solid tumors or lymphoma. Part 2 - evaluation of anti-tumor activity and confirmation of tolerability of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory osteosarcoma, Ewing sarcoma, RMS, and NRSTS.
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| From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| Number of Patients With Clinically Significant Laboratory Abnormalities | Blood and urine samples were collected to determine the clinical chemistry, hematology, and urinalysis laboratory abnormalities. | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| Number of Patients With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 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. | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| 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. |
| Disease Control Rate (DCR) | 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. | 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. |
| Time to Response (TTR) | 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. | 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. |
| Duration of Response (DoR) | The DoR was defined as the time from the first occurrence of PR or CR whichever came first, until disease progression or death. | 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. |
| Progression-Free Survival (PFS) | 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. | 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. |
| Number of Patients Who Performed Taste and Palatability Survey of Surufatinib | 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). | Days 1 and 8 of Cycle 1 |
| Orange |
| California |
| 92868 |
| United States |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Dose-Limiting Toxicities (DLT) | 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.
| 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. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to Day 35 of Cycle 1 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | 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. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| ||||||||||||||||||||||||||||||
| Primary | Number of Patients With Clinically Significant Physical Examination Abnormalities | 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. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| ||||||||||||||||||||||||||||||
| Primary | Number of Patients With Clinically Significant Vital Signs Abnormalities | Vital signs included systolic blood pressure (BP), diastolic BP, heart rate, height, weight, respiratory rate, and body temperature. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| ||||||||||||||||||||||||||||||
| Primary | Number of Patients With Clinically Significant Laboratory Abnormalities | Blood and urine samples were collected to determine the clinical chemistry, hematology, and urinalysis laboratory abnormalities. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
|
| |||||||||||||||||||||||||||||
| Primary | Number of Patients With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | 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. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Count of Participants | Participants | No | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | 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. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Number | 95% Confidence Interval | percentage of patients | 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. |
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | 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. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Number | 95% Confidence Interval | percentage of patients | 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. |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) | 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. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. No responders in this study. | Posted | 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. |
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| Secondary | Duration of Response (DoR) | The DoR was defined as the time from the first occurrence of PR or CR whichever came first, until disease progression or death. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. No responders in this study. | Posted | 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. |
|
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| Secondary | Progression-Free Survival (PFS) | 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. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Posted | Median | 95% Confidence Interval | months | 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. |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Performed Taste and Palatability Survey of Surufatinib | 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). | 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. | Posted | Count of Participants | Participants | No | Days 1 and 8 of Cycle 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level 1 | 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. | 6 | 10 | 7 | 10 | 10 | 10 |
| EG001 | 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. | 2 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal cord compression | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bicarbonate decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Lawn | HUTCHMED Limited | +44 7826 422448 | nickl@hutch-med.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2023 | Apr 18, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D012516 | Osteosarcoma |
| D012512 | Sarcoma, Ewing |
| D012208 | Rhabdomyosarcoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000717729 | surufatinib |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| White |
|
| Not Reported |
|
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