A Multi-Center, Open-Label Study of Surufatinib (HMPL-012... | NCT02549937 | Trialant
NCT02549937
Sponsor
Hutchmed
Status
Completed
Last Update Posted
Jul 10, 2024Actual
Enrollment
130Actual
Phase
Phase 1Phase 2
Conditions
Tumors
Interventions
surufatinib
Countries
United States
Italy
Protocol Section
Identification Module
NCT ID
NCT02549937
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2015-012-00US1
Secondary IDs
Not provided
Brief Title
A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors
Official Title
A Multi-Center, Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Surufatinib (HMPL-012), Previously Named Sulfatinib in Advanced Solid Tumors
Acronym
Not provided
Organization
HutchmedINDUSTRY
Status Module
Record Verification Date
Jul 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT04814732No longer available
Start Date
Nov 2015Actual
Primary Completion Date
Apr 25, 2023Actual
Completion Date
Jun 2, 2023Actual
First Submitted Date
Jul 13, 2015
First Submission Date that Met QC Criteria
Sep 13, 2015
First Posted Date
Sep 15, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 23, 2024
Results First Submitted that Met QC Criteria
Jul 8, 2024
Results First Posted Date
Jul 10, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 8, 2024
Last Update Posted Date
Jul 10, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
HutchmedINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Primary Objective Dose Escalation:
To evaluate the safety and tolerability of surufatinib in patients with advanced solid tumors and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D).
Primary Objective Dose Expansion:
To evaluate the anticancer activity of surufatinib in patients with advanced Biliary Tract Cancer (BTC), patients with advanced pancreatic neuroendocrine tumors (pNETs), patients with locally advanced, unresectable, metastatic extra-pancreatic neuroendocrine tumors (EP-NETs), and patients with soft tissue sarcomas (STS) treated at a dose of 300 mg QD.
Secondary Objective:
To evaluate the pharmacokinetic profile of multiple dose surufatinib in patients with advanced solid tumors and to evaluate the anti cancer activity of surufatinib in patients with advanced solid tumors.
Detailed Description
The study is an open-label, dose escalation and expansion clinical trial of surufatinib orally once daily (QD) in patients with advanced solid tumors.
The study consists of two phases:
Dose escalation phase - A 3+3 design will be used for this portion of the study.
Approximately 15 to 35 evaluable patients will be enrolled. The actual number of patients depends on the Dose-limiting toxicity (DLT) situation as well as the RP2D dose level reached in this trial.
The trial will approximately evaluate five surufatinib dose levels at 50,100, 200, 300 and 400 mg/day.
Expansion phase:
Approximately 115 patients will be enrolled into one of four open-label treatment arms during this phase: at least 30 patients with advanced BTC that has progressed on standard first-line chemotherapy will be assigned to Arm A, at least 15 patients with advanced pNET that has progressed on either everolimus, sunitinib, or both will be assigned to Arm B, at least 15 patients with advanced EP-NET that has progressed on everolimus will be assigned to Arm C, and at least 45 patients with Soft Tissue Sarcoma will be assigned to Arm D. Subjects enrolled in this phase are to be evaluated for the safety, tolerability and pharmacokinetic (PK) characteristics to confirm the selected surufatinib dose.
Subjects will receive surufatinib daily treatment continuously with every 28-day treatment cycle until disease progression, death, or intolerable toxicity at the investigator's discretion for a favorable benefit to risk balance.
Conditions Module
Conditions
Tumors
Keywords
biliary
pancreatic
neuroendocrine
carcinoid
PNET
EP-NET
extrapancreatic
sarcoma
soft tissue sarcoma
STS
BTC
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
130Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Escalation 50 mg
Experimental
Escalation cohort at 50 mg/day
Drug: surufatinib
Escalation 100mg
Experimental
Escalation cohort at 100 mg/day
Drug: surufatinib
Escalation 200 mg
Experimental
Escalation cohort at 200 mg/day
Drug: surufatinib
Escalation 300 mg
Experimental
Escalation cohort at 300 mg/day
Drug: surufatinib
Escalation 400 mg
Experimental
Escalation cohort at 400 mg/day
Drug: surufatinib
Expansion
Experimental
Subjects will receive RP2D surufatinib daily treatment continuously with every 28-day treatment cycle. Four expansion cohorts will enroll BTC, pNET, EP-NET, and STS patients, respectively.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
surufatinib
Drug
orally once daily (QD) in patients with advanced solid tumor.
Escalation 100mg
Escalation 200 mg
Escalation 300 mg
Escalation 400 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs)
A DLT was defined as any of the following toxicities determined by the Investigator to have a reasonable possibility of being related to surufatinib. Adverse events (AE) were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Any Grade 4 non-hematological toxicity; any Grade 3 non-hematological toxicity except for nausea/vomiting, diarrhea, constipation, electrolyte imbalances, or transient hypertension downgraded within 3 days with appropriate supportive treatment; Grade 4 neutropenia lasting >7 days; Grade 3 febrile neutropenia (absolute neutrophil count <1.0 × 10^9/liter (L) with a single temperature of >38.3 degree Celsius (°C) or a sustained temperature of >=38°C for more than 1 hour; Grade 4 thrombocytopenia or >=Grade 3 thrombocytopenia associated with tendency to bleed; dose interruption or delay for >14 days due to toxicity; any life-threatening complication or abnormality not covered in NCI CTCAE v. 4.03.
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug or other protocol-imposed drug, regardless of attribution. An SAE was an AE that resulted in any of the following outcomes: was fatal; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; a congenital anomaly/birth defect in a neonate/infant born to a female patient or female partner of a male patient exposed to the study drug(s); was considered a significant medical event by the Investigator. TEAEs were defined as any AEs that started or worsened in severity on or after the first administration date of study drug and no later than 30 (+7) days after the last administration date of study drug or initiation of new anti-tumor therapy (whichever occurred first).
From the first dose of study drug (Day 1) up to approximately 90 months
Dose-Expansion Phase: Arms A and D: Progression Free Survival (PFS) Rate at 16 Weeks
Secondary Outcomes
Measure
Description
Time Frame
Dose-Escalation and Dose-Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Surufatinib
Plasma samples were collected to determine Cmax of surufatinib. The pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Pre-dose and 1, 2, 4, 6, 8 hours post-dose on Days 1 and 15 of Cycle 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Fully understand the study and voluntarily sign the informed consent form;
At least 18 years old;
Histologically or cytologically documented, locally advanced or metastatic solid malignancy of any type during the dose escalation phase, that has progressed on available standard systemic therapy, and for whom no effective therapy or standard of care exists; and locally advanced or metastatic BTC that has progressed on standard first-line chemotherapy; locally advanced or metastatic pNET that has progressed on everolimus, sunitinib or both; locally advanced or metastatic EP-NET that has progressed on everolimus; advanced STS that has progressed on at least one line of standard therapy or refused standard frontline cytotoxic chemotherapy during the expansion phase;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
Hypertension that is not controlled by antihypertension medication, defined as: systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg;
History or presence of digestive tract diseases, including active gastric/duodenal ulcer or ulcerative colitis, or active hemorrhage of an unresected gastrointestinal tumor, or an evaluation by investigators of having any other condition that could possibly result in gastrointestinal tract hemorrhage or perforation;
History or presence of serious hemorrhage , hemoptysis or hematemesis within 3 months or a thromboembolic event (including Deep Vein Thrombosis (DVT), stroke and/or transient ischemic attack) within 6 months;
Patients with squamous Non Small Cell Lung Cancer (NSCLC) should be excluded;
Clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris or coronary artery bypass grafting, New York Heart Association Class III/IV congestive heart failure, ventricular arrhythmias requiring treatment or left ventricular ejection fraction (LVEF) < 50%;
Systemic anti-neoplastic therapies within 4 weeks prior to the initiation of investigational treatment, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy and immunotherapy;
Palliative radiotherapy for bone metastasis/lesion within 2 weeks;
Known Human immunodeficiency virus (HIV) infection;
Known clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis;
Women who are pregnant or lactating;
Brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease for 14 days or longer; Subjects requiring steroids within 4 weeks prior to start of study treatment will be excluded;
Inability to take medication orally, dysphagia or an active gastric ulcer resulting from previous surgery or a severe gastrointestinal disease, or any other condition that investigators believe may affect absorption of the investigational product;
Received investigational treatment in another clinical study within 4 weeks prior to the initiation of investigational treatment;
Other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may prohibit use of the investigational product, affect interpretation of study results, or put the patient at high risk.
Dasari A, Hamilton EP, Falchook GS, Wang JS, Li D, Sung MW, Chien C, Nanda S, Tucci C, Hahka-Kemppinen M, Paulson AS. A dose escalation/expansion study evaluating dose, safety, and efficacy of the novel tyrosine kinase inhibitor surufatinib, which inhibits VEGFR 1, 2, & 3, FGFR 1, and CSF1R, in US patients with neuroendocrine tumors. Invest New Drugs. 2023 Jun;41(3):421-430. doi: 10.1007/s10637-023-01359-2. Epub 2023 Apr 19.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study consisted of a Dose-Escalation phase in patients with advanced solid tumors of any type and a Dose-Expansion phase in patients with advanced biliary tract cancer (BTC) (Arm A), advanced pancreatic neuroendocrine tumor (pNETs) (Arm B), advanced extrapancreatic neuroendocrine tumor (epNETs) (Arm C), or soft tissue sarcoma (STS) (Arm D). A total of 35 patients in Dose-Escalation phase and 95 patients in Dose-Expansion phase were enrolled in this study.
Recruitment Details
This Phase 1/1b, 2-part, open-label study was conducted in patients with advanced solid tumors at 12 investigational sites in the United States and Italy.
Patients received surufatinib 50 mg orally once daily (QD) throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 19, 2021
Apr 18, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: surufatinib
Escalation 50 mg
Expansion
HMPL-012
sulfatinib
The tumor response was determined according to the international Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 guideline. PFS is defined as the time (in months) from the start date of study medication (Day 1) until the date of objective disease progression as defined by RECIST Version 1.1 or death (by any cause in the absence of progression), whichever occurred earlier. PFS rate probability at 16 week was estimated. Progression is defined by RECIST v1.0 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline or appearance of 1 or more new lesions.
At 16 weeks
Dose-Expansion Phase: Arms B and C: PFS Rate at 11 Months
The tumor response was determined according to the RECIST v1.1 guideline. PFS is defined as the time (in months) from the start date of study medication (Day 1) until the date of objective disease progression as defined by RECIST Version 1.1 or death (by any cause in the absence of progression), whichever occurred earlier. PFS rate probability at 11 months was estimated. Progression is defined by RECIST v1.0 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline or appearance of 1 or more new lesions.
At 11 months
Dose Escalation and Dose-Expansion Phase: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Surufatinib
Plasma samples were collected to determine Tmax of surufatinib. The PK parameters were determined by non-compartmental analysis.
Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15 of Cycle 1
Dose-Escalation and Dose-Expansion Phase: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Surufatinib
Plasma samples were collected to determine AUC0-24h of surufatinib. The PK parameters were determined by non-compartmental analysis. Data from pre-dose to 8 hours post-dose were extrapolated to obtain the AUC0-24 data.
Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
Dose-Escalation and Dose-Expansion Phase: AUC Over the Dosing Interval (AUCtau) of Surufatinib
Plasma samples were collected to determine AUCtau of surufatinib. The PK parameters were determined by non-compartmental analysis.
Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1
Dose-Escalation and Dose-Expansion Phase: Objective Response Rate (ORR)
The ORR was defined as the percentage of patients achieving a complete response (CR) or partial response (PR) as confirmed best overall response (BOR) as determined by the Investigator using RECIST v1.1. 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.
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
Dose-Escalation and Dose-Expansion Phase: Disease Control Rate (DCR)
The DCR was defined as the percentage of patients who achieved a CR, PR or stable disease (SD) as confirmed BOR as determined by the Investigator using RECIST v1.1. 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. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study.
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
Dose-Escalation and Dose-Expansion Phase: Duration of Response (DoR)
The DoR was defined as the time from the first time that the objective response reached CR or PR, whichever came first (and later confirmed), until the occurrence of PD or death. 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 PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. The appearance of 1 or more new lesions was also considered progression.
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
The PFS was defined as the time from the start date of study drug until the date of objective PD as assessed by the Investigator using RECIST version 1.1 or death (by any cause in the absence of progression).
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 53 months
Dose-Expansion Phase: Time to Response (TTR)
The TTR was defined as the time from the start of study drug until first documented response (and later confirmed) according to RECIST v.1.1 for responders only.
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 53 months
Dose-Escalation and Dose-Expansion Phase: Maximum Percentage Change From Baseline in Tumor Size as Per RECIST v1.1
Percentage change in tumor size was determined for patients with measurable disease at baseline and was derived at each visit by the percentage change in the sum of the diameters of target lesions compared to baseline, mean of maximum percentage change is presented. Baseline was defined as the last evaluable tumor assessment result obtained prior to the administration of study drug (including unscheduled assessments).
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
Denver
Colorado
80218
United States
SCRI at HealthONE
Denver
Colorado
80218
United States
Florida Cancer Specialists
Sarasota
Florida
34232
United States
Mount Sinai Hospital
New York
New York
10029
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10072
United States
Tennessee Oncology
Nashville
Tennessee
37203
United States
Mary Crowley Cancer Research Center
Dallas
Texas
75230
United States
Baylor Charles A. Sammons Cancer Center
Dallas
Texas
75246
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Italy
FG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG005
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG006
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG007
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG008
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
FG0003 subjects
FG0017 subjects
FG0023 subjects
FG0039 subjects
FG00413 subjects
FG00530 subjects
FG00616 subjects
FG00716 subjects
FG00833 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
NOT COMPLETED
FG0003 subjects
FG0017 subjects
FG0023 subjects
FG0039 subjects
FG00413 subjects
FG00530 subjects
FG00616 subjects
FG00716 subjects
FG00833 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0058 subjects
FG0060 subjects
FG0070 subjects
FG00819 subjects
No follow up required
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0038 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The Safety analysis set included all patients who received at least 1 dose of surufatinib.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
BG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG005
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG006
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG007
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG008
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0017
BG0023
BG0039
BG00413
BG00530
BG00616
BG00716
BG00833
BG009130
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00050.9± 4.16
BG00158.1± 8.27
BG00261.3± 7.04
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Asian
Title
Measurements
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0000
BG0011
BG002
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
Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs)
A DLT was defined as any of the following toxicities determined by the Investigator to have a reasonable possibility of being related to surufatinib. Adverse events (AE) were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Any Grade 4 non-hematological toxicity; any Grade 3 non-hematological toxicity except for nausea/vomiting, diarrhea, constipation, electrolyte imbalances, or transient hypertension downgraded within 3 days with appropriate supportive treatment; Grade 4 neutropenia lasting >7 days; Grade 3 febrile neutropenia (absolute neutrophil count <1.0 × 10^9/liter (L) with a single temperature of >38.3 degree Celsius (°C) or a sustained temperature of >=38°C for more than 1 hour; Grade 4 thrombocytopenia or >=Grade 3 thrombocytopenia associated with tendency to bleed; dose interruption or delay for >14 days due to toxicity; any life-threatening complication or abnormality not covered in NCI CTCAE v. 4.03.
The DLT Evaluable set included all patients in Safety analysis set who were evaluable for DLT assessment. A patient was DLT evaluable if: had not received any preventive treatment during the DLT period and had completed the first 28-day treatment cycle with complete safety evaluations and had received at least 75% of the assigned surufatinib dose or had a confirmed DLT during the first 28-day treatment cycle.
Posted
Count of Participants
Participants
No
From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Primary
Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug or other protocol-imposed drug, regardless of attribution. An SAE was an AE that resulted in any of the following outcomes: was fatal; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; a congenital anomaly/birth defect in a neonate/infant born to a female patient or female partner of a male patient exposed to the study drug(s); was considered a significant medical event by the Investigator. TEAEs were defined as any AEs that started or worsened in severity on or after the first administration date of study drug and no later than 30 (+7) days after the last administration date of study drug or initiation of new anti-tumor therapy (whichever occurred first).
The Safety analysis set included all patients who received at least 1 dose of surufatinib.
Posted
Count of Participants
Participants
No
From the first dose of study drug (Day 1) up to approximately 90 months
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Primary
Dose-Expansion Phase: Arms A and D: Progression Free Survival (PFS) Rate at 16 Weeks
The tumor response was determined according to the international Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 guideline. PFS is defined as the time (in months) from the start date of study medication (Day 1) until the date of objective disease progression as defined by RECIST Version 1.1 or death (by any cause in the absence of progression), whichever occurred earlier. PFS rate probability at 16 week was estimated. Progression is defined by RECIST v1.0 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline or appearance of 1 or more new lesions.
The Safety analysis set included all patients who received at least 1 dose of surufatinib.
Posted
Number
95% Confidence Interval
percentage of patients
At 16 weeks
ID
Title
Description
OG000
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG001
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Primary
Dose-Expansion Phase: Arms B and C: PFS Rate at 11 Months
The tumor response was determined according to the RECIST v1.1 guideline. PFS is defined as the time (in months) from the start date of study medication (Day 1) until the date of objective disease progression as defined by RECIST Version 1.1 or death (by any cause in the absence of progression), whichever occurred earlier. PFS rate probability at 11 months was estimated. Progression is defined by RECIST v1.0 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline or appearance of 1 or more new lesions.
The Safety analysis set included all patients who received at least 1 dose of surufatinib.
Posted
Number
95% Confidence Interval
percentage of patients
At 11 months
ID
Title
Description
OG000
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG001
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Secondary
Dose-Escalation and Dose-Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Surufatinib
Plasma samples were collected to determine Cmax of surufatinib. The pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
The PK analysis set included all patients whose plasma samples were collected for surufatinib concentration measurement and derivation of PK parameters. Combined data is presented for all patients evaluable for PK parameters who received surufatinib 300 mg in Dose-Escalation and Dose-Expansion phase. Only those patients with data collected at specified timepoints are reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram/milliliter (ng/mL)
Pre-dose and 1, 2, 4, 6, 8 hours post-dose on Days 1 and 15 of Cycle 1
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Secondary
Dose Escalation and Dose-Expansion Phase: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Surufatinib
Plasma samples were collected to determine Tmax of surufatinib. The PK parameters were determined by non-compartmental analysis.
The PK analysis set included all patients whose plasma samples were collected for surufatinib concentration measurement and derivation of PK parameters. Combined data is presented for all patients evaluable for PK parameters who received surufatinib 300 mg in Dose-Escalation and Dose-Expansion phase. Only those patients with data collected at specified timepoints are reported.
Posted
Median
Full Range
hour
Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15 of Cycle 1
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Secondary
Dose-Escalation and Dose-Expansion Phase: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Surufatinib
Plasma samples were collected to determine AUC0-24h of surufatinib. The PK parameters were determined by non-compartmental analysis. Data from pre-dose to 8 hours post-dose were extrapolated to obtain the AUC0-24 data.
The PK analysis set included all patients whose plasma samples were collected for surufatinib concentration measurement and derivation of PK parameters. Combined data is presented for all patients evaluable for PK parameters who received surufatinib 300 mg in Dose-Escalation and Dose-Expansion phase. Only those patients with data collected at specified timepoints are reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Secondary
Dose-Escalation and Dose-Expansion Phase: AUC Over the Dosing Interval (AUCtau) of Surufatinib
Plasma samples were collected to determine AUCtau of surufatinib. The PK parameters were determined by non-compartmental analysis.
The PK analysis set included all patients whose plasma samples were collected for surufatinib concentration measurement and derivation of PK parameters. Combined data is presented for all patients evaluable for PK parameters who received surufatinib 300 mg in Dose-Escalation and Dose-Expansion phase. Only those patients with data collected at specified timepoints are reported.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Secondary
Dose-Escalation and Dose-Expansion Phase: Objective Response Rate (ORR)
The ORR was defined as the percentage of patients achieving a complete response (CR) or partial response (PR) as confirmed best overall response (BOR) as determined by the Investigator using RECIST v1.1. 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 Efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment.
Posted
Number
95% Confidence Interval
percentage of patients
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Secondary
Dose-Escalation and Dose-Expansion Phase: Disease Control Rate (DCR)
The DCR was defined as the percentage of patients who achieved a CR, PR or stable disease (SD) as confirmed BOR as determined by the Investigator using RECIST v1.1. 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. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study.
The Efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment.
Posted
Number
95% Confidence Interval
percentage of patients
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Secondary
Dose-Escalation and Dose-Expansion Phase: Duration of Response (DoR)
The DoR was defined as the time from the first time that the objective response reached CR or PR, whichever came first (and later confirmed), until the occurrence of PD or death. 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 PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. The appearance of 1 or more new lesions was also considered progression.
The Efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment. Only those patients with PR or CR (responders) were included in the analysis.
Posted
Median
95% Confidence Interval
months
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
The PFS was defined as the time from the start date of study drug until the date of objective PD as assessed by the Investigator using RECIST version 1.1 or death (by any cause in the absence of progression).
The Safety analysis set included all patients who received at least 1 dose of surufatinib.
Posted
Median
95% Confidence Interval
months
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 53 months
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Secondary
Dose-Expansion Phase: Time to Response (TTR)
The TTR was defined as the time from the start of study drug until first documented response (and later confirmed) according to RECIST v.1.1 for responders only.
The Efficacy analysis set included all patients who received at least 1 dose of study medication and had at least 1 post-baseline tumor assessment. Only those patients who achieved CR/PR (responders) were included in the analysis.
Posted
Median
Full Range
months
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 53 months
ID
Title
Description
OG000
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG001
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG002
Secondary
Dose-Escalation and Dose-Expansion Phase: Maximum Percentage Change From Baseline in Tumor Size as Per RECIST v1.1
Percentage change in tumor size was determined for patients with measurable disease at baseline and was derived at each visit by the percentage change in the sum of the diameters of target lesions compared to baseline, mean of maximum percentage change is presented. Baseline was defined as the last evaluable tumor assessment result obtained prior to the administration of study drug (including unscheduled assessments).
The Efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment. Only those patients with data collected are reported.
Posted
Mean
Standard Deviation
percentage change
RECIST assessments performed at screening (within 28 days before start of study treatment), Day 1 of Cycle 2, and every 8 (+/-1 week) weeks afterwards until the occurrence of disease progression, up to a maximum of 90 months
ID
Title
Description
OG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Time Frame
TEAEs and all-cause mortality were collected from the first dose of study drug (Day 1) up to approximately 90 months
Description
The Safety analysis set included all patients who received at least 1 dose of surufatinib.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Dose-Escalation Phase: Surufatinib 50 mg
Patients received surufatinib 50 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment that the patient can no longer benefit from the study drug.
0
3
1
3
3
3
EG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
1
7
2
7
7
7
EG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
0
3
0
3
3
3
EG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
1
9
4
9
9
9
EG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
0
13
4
13
13
13
EG005
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
8
30
11
30
26
30
EG006
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
0
16
8
16
15
16
EG007
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
0
16
7
16
16
16
EG008
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
20
33
15
33
31
33
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected9 at risk
EG0040 events0 affected13 at risk
EG0050 events0 affected30 at risk
EG0060 events0 affected16 at risk
EG0070 events0 affected16 at risk
EG0080 events0 affected33 at risk
Bacteraemia
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Disease progression
General disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected3 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug
OG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG0039
OG00413
Title
Denominators
Categories
Any TEAEs
Title
Measurements
OG0003
OG0017
OG0023
OG0039
OG00413
Any TESAEs
Title
Measurements
OG0001
OG0012
OG0020
OG003
Units
Counts
Participants
OG00030
OG00133
Title
Denominators
Categories
Title
Measurements
OG00050.1(27.8 to 68.9)
OG00126.5(11.4 to 44.2)
Units
Counts
Participants
OG00016
OG00116
Title
Denominators
Categories
Title
Measurements
OG00064.6(34.7 to 83.5)
OG00160.9(24.3 to 84.0)
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation and Dose-Expansion Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG00379
OG00413
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00379
ParticipantsOG00413
Title
Measurements
OG00073.6± 39.2
OG001149± 107.3
OG002180± 39.3
OG003
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00370
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation and Dose-Expansion Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG00379
OG00413
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00379
ParticipantsOG00413
Title
Measurements
OG0002.00(1.02 to 2.17)
OG0011.03(1.00 to 4.00)
OG0022.05(1.02 to 3.58)
OG003
Cycle 1 Day 15
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0023
ParticipantsOG00370
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation and Dose-Expansion Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG00368
OG00412
Title
Denominators
Categories
Title
Measurements
OG000616± 7.5
OG001877± 81.2
OG0021360± 10.5
OG0033080± 58.8
OG0043540± 76.8
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation and Dose-Expansion Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG00367
OG00410
Title
Denominators
Categories
Title
Measurements
OG000968± 1.5
OG0011320± 95.2
OG0022310± 36.7
OG0034770± 64.4
OG0046890± 60.5
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG005
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG006
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG007
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG008
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0038
OG00411
OG00527
OG00616
OG00716
OG00830
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 70.8)
OG0010.0(0.0 to 45.9)
OG0020.0(0.0 to 70.8)
OG0030.0(0.0 to 36.9)
OG0049.1(0.2 to 41.3)
OG0050.0(0.0 to 12.8)
OG00618.8(4.0 to 45.6)
OG0076.3(0.2 to 30.2)
OG0080.0(0.0 to 11.6)
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG005
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG006
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG007
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG008
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0038
OG00411
OG00527
OG00616
OG00716
OG00830
Title
Denominators
Categories
Title
Measurements
OG00033.3(0.8 to 90.6)
OG00150.0(11.8 to 88.2)
OG00233.3(0.8 to 90.6)
OG00350.0(15.7 to 84.3)
OG00472.7(39.0 to 94.0)
OG00548.1(28.7 to 68.1)
OG00687.5(61.7 to 98.4)
OG00793.8(69.8 to 99.8)
OG00830.0(14.7 to 49.4)
OG001
Dose-Escalation Phase: Surufatinib 100 mg
Patients received surufatinib 100 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG005
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG006
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG007
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG008
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0063
OG0071
OG0080
Title
Denominators
Categories
Title
Measurements
OG00413.142(NA to NA)NA indicates that upper and lower limits of confidence interval (CI) were not estimable due to insufficient number of patients with events at study closure.
OG006NA(14.752 to NA)NA indicates that median and upper limit of CI were not estimable due to insufficient number of patients with events at study closure.
OG00714.784(NA to NA)NA indicates that upper and lower limits of CI were not estimable due to insufficient number of patients with events at study closure.
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0003
OG0017
OG0023
OG0039
OG00413
Title
Denominators
Categories
Title
Measurements
OG0002.793(1.873 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0012.530(0.887 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0025.322(0.920 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
OG0032.694(1.676 to 3.680)
OG0048.378(1.741 to NA)NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0000
OG0013
OG0021
OG0030
Title
Denominators
Categories
Title
Measurements
OG0012.760(2.69 to 4.63)
OG0022.497(2.497 to 2.497)
OG002
Dose-Escalation Phase: Surufatinib 200 mg
Patients received surufatinib 200 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG003
Dose-Escalation Phase: Surufatinib 300 mg
Patients received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG004
Dose-Escalation Phase: Surufatinib 400 mg
Patients received surufatinib 400 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG005
Dose-Expansion Phase: Arm A: BTC
Patients with advanced BTC received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG006
Dose-Expansion Phase: Arm B: pNET
Patients with advanced pNET received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG007
Dose-Expansion Phase: Arm C: epNET
Patients with advanced epNETs received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
OG008
Dose-Expansion Phase: Arm D: STS
Patients with STS received surufatinib 300 mg orally QD throughout each 28-day treatment cycle until disease progression, death, intolerable toxicity, pregnancy, withdrawal of consent, or an Investigator's assessment of loss of benefit from the study drug.
Units
Counts
Participants
OG0001
OG0016
OG0023
OG0038
OG00411
OG00525
OG00616
OG00716
OG00830
Title
Denominators
Categories
Title
Measurements
OG000-17.895± NANA indicates that standard deviation cannot be derived for a single patient.