Trial · NCT02549937
A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors
NCT02549937, Phase 1, Phase 2, Completed, Hutchmed; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors. Trials, record NCT02549937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02549937
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors
- NCT number
- NCT02549937
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- Hutchmed
- Conditions
- Tumors
- Interventions
- surufatinib
- First posted
- 2015-09-15
- Last updated
- 2024-07-10
- Results first posted
- 2024-07-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs) | From the first dose of study drug (Day 1) up to Day 28 of Cycle 1 | 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. |
| Primary | Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the first dose of study drug (Day 1) up to approximately 90 months | 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). |
| Primary | Dose-Expansion Phase: Arms A and D: Progression Free Survival (PFS) Rate at 16 Weeks | 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. |
| Primary | Dose-Expansion Phase: Arms B and C: PFS Rate at 11 Months | 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. |
| Secondary | Dose-Escalation and Dose-Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Surufatinib | Pre-dose and 1, 2, 4, 6, 8 hours post-dose on Days 1 and 15 of Cycle 1 | Plasma samples were collected to determine Cmax of surufatinib. The pharmacokinetic (PK) parameters were determined by non-compartmental analysis. |
| Secondary | Dose Escalation and Dose-Expansion Phase: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Surufatinib | Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15 of Cycle 1 | Plasma samples were collected to determine Tmax of surufatinib. The PK parameters were determined by non-compartmental analysis. |
| Secondary | Dose-Escalation and Dose-Expansion Phase: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Surufatinib | Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 | 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. |
| Secondary | Dose-Escalation and Dose-Expansion Phase: AUC Over the Dosing Interval (AUCtau) of Surufatinib | Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1 | Plasma samples were collected to determine AUCtau of surufatinib. The PK parameters were determined by non-compartmental analysis. |
| Secondary | Dose-Escalation and Dose-Expansion Phase: Objective Response Rate (ORR) | 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 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. |
| Secondary | Dose-Escalation and Dose-Expansion Phase: Disease Control Rate (DCR) | 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 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs) | From the first dose of study drug (Day 1) up to Day 28 of Cycle 1 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | From the first dose of study drug (Day 1) up to approximately 90 months | The Safety analysis set included all patients who received at least 1 dose of surufatinib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose-Expansion Phase: Arms A and D: Progression Free Survival (PFS) Rate at 16 Weeks | At 16 weeks | The Safety analysis set included all patients who received at least 1 dose of surufatinib. | percentage of patients | NUMBER |
| PRIMARY | Dose-Expansion Phase: Arms B and C: PFS Rate at 11 Months | At 11 months | The Safety analysis set included all patients who received at least 1 dose of surufatinib. | percentage of patients | NUMBER |
| SECONDARY | Dose-Escalation and Dose-Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Surufatinib | Pre-dose and 1, 2, 4, 6, 8 hours post-dose on Days 1 and 15 of Cycle 1 | 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. | nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Dose Escalation and Dose-Expansion Phase: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Surufatinib | Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Days 1 and 15 of Cycle 1 | 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. | hour | MEDIAN |
| SECONDARY | Dose-Escalation and Dose-Expansion Phase: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of Surufatinib | Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Cycle 1 Day 1 | 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. | hour*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Dose-Escalation and Dose-Expansion Phase: AUC Over the Dosing Interval (AUCtau) of Surufatinib | Pre-dose and 1, 2, 4, 6, and 8 hours post-dose on Day 15 of Cycle 1 | 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. | hour*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Dose-Escalation and Dose-Expansion Phase: Objective Response Rate (ORR) | 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 Efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment. | percentage of patients | NUMBER |
| SECONDARY | Dose-Escalation and Dose-Expansion Phase: Disease Control Rate (DCR) | 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 Efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment. | percentage of patients | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose-Escalation Phase: Surufatinib 50 mg | 0 | Participants | ||
| Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose-Escalation Phase: Surufatinib 100 mg | 1 | Participants | ||
| Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose-Escalation Phase: Surufatinib 200 mg | 0 | Participants | ||
| Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose-Escalation Phase: Surufatinib 300 mg | 1 | Participants | ||
| Dose-Escalation Phase: Number of Patients With Dose-Limiting Toxicities (DLTs) | Dose-Escalation Phase: Surufatinib 400 mg | 3 | Participants | ||
| Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-Escalation Phase: Surufatinib 50 mg | Any TEAEs | 3 | Participants | |
| Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-Escalation Phase: Surufatinib 100 mg | Any TEAEs | 7 | Participants | |
| Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-Escalation Phase: Surufatinib 200 mg | Any TEAEs | 3 | Participants | |
| Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-Escalation Phase: Surufatinib 300 mg | Any TEAEs | 9 | Participants | |
| Dose-Escalation Phase: Number of Patients With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Dose-Escalation Phase: Surufatinib 400 mg | Any TEAEs | 13 | Participants |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose-Escalation Phase: Surufatinib 50 Milligrams (mg) | 3 | |
| Overall Study | STARTED | Dose-Escalation Phase: Surufatinib 100 mg | 7 | |
| Overall Study | STARTED | Dose-Escalation Phase: Surufatinib 200 mg | 3 | |
| Overall Study | STARTED | Dose-Escalation Phase: Surufatinib 300 mg | 9 | |
| Overall Study | STARTED | Dose-Escalation Phase: Surufatinib 400 mg | 13 | |
| Overall Study | STARTED | Dose-Expansion Phase: Arm A: BTC | 30 | |
| Overall Study | STARTED | Dose-Expansion Phase: Arm B: pNET | 16 | |
| Overall Study | STARTED | Dose-Expansion Phase: Arm C: epNET | 16 | |
| Overall Study | STARTED | Dose-Expansion Phase: Arm D: STS | 33 | |
| Overall Study | COMPLETED | Dose-Escalation Phase: Surufatinib 50 Milligrams (mg) | 0 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events855
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Dose-Escalation Phase: Surufatinib 50 mg | 1 | 3 | 1 |
| other | Nausea | Gastrointestinal disorders | Dose-Escalation Phase: Surufatinib 100 mg | 4 | 7 | 5 |
| other | Nausea | Gastrointestinal disorders | Dose-Escalation Phase: Surufatinib 200 mg | 1 | 3 | 1 |
| other | Nausea | Gastrointestinal disorders | Dose-Escalation Phase: Surufatinib 300 mg | 4 | 9 | 5 |
| other | Nausea | Gastrointestinal disorders | Dose-Escalation Phase: Surufatinib 400 mg | 7 | 13 | 9 |
| other | Nausea | Gastrointestinal disorders | Dose-Expansion Phase: Arm A: BTC | 8 | 30 | 8 |
| other | Nausea | Gastrointestinal disorders | Dose-Expansion Phase: Arm B: pNET | 5 | 16 | 6 |
| other | Nausea | Gastrointestinal disorders | Dose-Expansion Phase: Arm C: epNET | 5 | 16 | 9 |
| other | Nausea | Gastrointestinal disorders | Dose-Expansion Phase: Arm D: STS | 6 | 33 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | Dose-Escalation Phase: Surufatinib 50 mg | 1 | 3 | 2 |
1 to 10 of 855Source ClinicalTrials.gov
See all 855 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose-Escalation Phase: Surufatinib 50 mg | 0 | 3 |
| Total, all-cause mortality | Dose-Escalation Phase: Surufatinib 100 mg | 1 | 7 |
| Total, all-cause mortality | Dose-Escalation Phase: Surufatinib 200 mg | 0 | 3 |
| Total, all-cause mortality | Dose-Escalation Phase: Surufatinib 300 mg | 1 | 9 |
| Total, all-cause mortality | Dose-Escalation Phase: Surufatinib 400 mg | 0 | 13 |
| Total, all-cause mortality | Dose-Expansion Phase: Arm A: BTC | 8 | 30 |
| Total, all-cause mortality | Dose-Expansion Phase: Arm B: pNET | 0 | 16 |
| Total, all-cause mortality | Dose-Expansion Phase: Arm C: epNET | 0 | 16 |
| Total, all-cause mortality | Dose-Expansion Phase: Arm D: STS | 20 | 33 |
| Total, other adverse events | Dose-Escalation Phase: Surufatinib 50 mg | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37074571 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02549937
GET https://conductscience.org/api/trials/v1/NCT02549937/results?page=2