Trial · NCT05093322
A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
NCT05093322, Phase 1, Phase 2, Completed, Hutchmed; results first posted 2024-05-16
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors. Trials, record NCT05093322. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05093322
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
- NCT number
- NCT05093322
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Hutchmed
- Conditions
- Solid Tumor, Lymphoma, Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, Non-rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
- Interventions
- Surufatinib in combination with Gemcitabine
- First posted
- 2021-10-26
- Last updated
- 2024-06-07
- Other registries' IDs
- eudract:2021-003602-41
- Results first posted
- 2024-05-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Dose-Limiting Toxicities (DLT) | From the first dose of study drug (Day 1) up to Day 35 of Cycle 1 | A DLT was defined as any of following events that were attributable to study treatment (at least possibly related). Adverse events (AE) were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. * Any Grade 3 or greater nonhematological toxicity. * Grade 3 liver enzyme elevation. * Cases of Hy's law. * Any Grade 2 nonhematological toxicity that persisted for \>= 7 days. * Any Grade 4 hypertension. * Grade 3 corrected QT interval prolongation \> 500 millisecond. * Grade 4 thrombocytopenia for \> 7 days. * Grade 3 thrombocytopenia with clinically significant bleeding. * Grade 4 neutropenia that lasted for \> 7 days. * Myelosuppression that caused a delay of \> 7 days in the start of Cycle 2. |
| Primary | Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | The AEs were graded using the NCI CTCAE version 5.0. The CTCAE displays Grades 1 through 5 where, Grade 1= mild, Grade 2= moderate, Grade 3= Severe, Grade 4= life-threatening consequences and Grade 5= death. |
| Primary | Number of Patients With Clinically Significant Physical Examination Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | Physical examination included patient height, weight, and general condition, as well as an examination of the head, heart, chest (including the lungs), abdomen, extremities, skin, lymph nodes, nervous system, and additional areas/systems as clinically indicated. |
| Primary | Number of Patients With Clinically Significant Vital Signs Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | Vital signs included systolic blood pressure (BP), diastolic BP, heart rate, height, weight, respiratory rate, and body temperature. |
| Primary | Number of Patients With Clinically Significant Laboratory Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | Blood and urine samples were collected to determine the clinical chemistry, hematology, and urinalysis laboratory abnormalities. |
| Primary | Number of Patients With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | Standard 12-lead ECGs were performed after the patient rested for 5 to 10 minutes. The ECG parameters included heart rate, PR interval, RR interval, QT interval, QTcF, and QRS interval from the triplicate 12-lead ECG. |
| Secondary | Objective Response Rate (ORR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The ORR was defined as the percentage of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST version 1.1 progression, death, or withdrawal of consent. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Disease Control Rate (DCR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease as determined by the investigator using RECIST version 1.1. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study. |
| Secondary | Time to Response (TTR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The TTR was defined as the time from the start of study treatment until the date of the first occurrence of PR or CR for responders only. |
| Secondary | Duration of Response (DoR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The DoR was defined as the time from the first occurrence of PR or CR whichever came first, until disease progression or death. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Dose-Limiting Toxicities (DLT) | From the first dose of study drug (Day 1) up to Day 35 of Cycle 1 | The DLT evaluable set included all patients enrolled in dose escalation phase of study who received at least 80% of surufatinib dose and both doses of gemcitabine during DLT evaluation period or who discontinued treatment due to a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Clinically Significant Physical Examination Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Clinically Significant Vital Signs Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Clinically Significant Laboratory Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Patients With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | From the first dose of study drug (Day 1) up to 30 + 7 days after the last dose of study drug, approximately 19 weeks | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | percentage of patients | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. | percentage of patients | NUMBER |
| SECONDARY | Time to Response (TTR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. No responders in this study. | ||
| SECONDARY | Duration of Response (DoR) | RECIST assessments performed at baseline (within 28 days before start of study treatment), Day 1 of Cycle 3 and until confirmed objective disease progression. Up to approximately 19 weeks. | The Safety analysis set included all patients who received at least 1 dose of surufatinib or gemcitabine. No responders in this study. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Dose-Limiting Toxicities (DLT) | Dose Level 1 | 0 | Participants | ||
| Number of Patients With Dose-Limiting Toxicities (DLT) | Dose Level 2 | 2 | Participants | ||
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 1 | Grade 1 | 0 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 2 | Grade 1 | 0 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 1 | Grade 2 | 1 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 2 | Grade 2 | 1 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 1 | Grade 3 | 4 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 2 | Grade 3 | 2 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 1 | Grade 4 | 3 | Participants | |
| Number of Patients With Treatment Emergent Adverse Events (TEAEs) by Severity | Dose Level 2 | Grade 4 | 0 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1 | 10 | |
| Overall Study | STARTED | Dose Level 2 | 3 | |
| Overall Study | COMPLETED | Dose Level 1 | 0 | |
| Overall Study | COMPLETED | Dose Level 2 | 0 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 10 | |
| Overall Study | NOT COMPLETED | Dose Level 2 | 3 |
Source ClinicalTrials.gov
Adverse events204
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 | Hypertension | Vascular disorders | Dose Level 1 | 2 | 10 | 3 |
| other | Hypertension | Vascular disorders | Dose Level 2 | 2 | 3 | 3 |
| other | Hypotension | Vascular disorders | Dose Level 1 | 1 | 10 | 1 |
| other | Hypotension | Vascular disorders | Dose Level 2 | 0 | 3 | 0 |
| other | Pyrexia | General disorders | Dose Level 1 | 5 | 10 | 6 |
| other | Pyrexia | General disorders | Dose Level 2 | 2 | 3 | 2 |
| other | Fatigue | General disorders | Dose Level 1 | 3 | 10 | 4 |
| other | Fatigue | General disorders | Dose Level 2 | 2 | 3 | 2 |
| other | Non-cardiac chest pain | General disorders | Dose Level 1 | 2 | 10 | 3 |
| other | Non-cardiac chest pain | General disorders | Dose Level 2 | 1 | 3 | 1 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1 | 6 | 10 |
| Total, all-cause mortality | Dose Level 2 | 2 | 3 |
| Total, other adverse events | Dose Level 1 | 10 | 10 |
| Total, other adverse events | Dose Level 2 | 3 | 3 |
| Total, serious adverse events | Dose Level 1 | 7 | 10 |
| Total, serious adverse events | Dose Level 2 | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Level 1 vs Dose Level 2: Number of Patients With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities | Trial comparisons |
| Dose Level 1 vs Dose Level 2: Number of Patients With Clinically Significant Laboratory Abnormalities | Trial comparisons |
| Dose Level 1 vs Dose Level 2: Number of Patients With Clinically Significant Physical Examination Abnormalities | Trial comparisons |
| Dose Level 1 vs Dose Level 2: deaths from any cause | Trial comparisons |
| Dose Level 1 vs Dose Level 2: Number of Patients With Clinically Significant Vital Signs Abnormalities | Trial comparisons |
| Dose Level 1 vs Dose Level 2: Number of Patients With Dose-Limiting Toxicities (DLT) | Trial comparisons |
| Dose Level 1 vs Dose Level 2: serious adverse events | Trial comparisons |
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/NCT05093322
GET https://conductscience.org/api/trials/v1/NCT05093322/results?page=2