Trial · NCT05093322
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Secondary | Progression-Free Survival (PFS) | 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 PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST version 1.1 or death from any cause. |
| Secondary | Number of Patients Who Performed Taste and Palatability Survey of Surufatinib | Days 1 and 8 of Cycle 1 | The taste and palatability survey was assessed in patients who had taken surufatinib oral suspension. For pediatric patients, their parents completed the taste and palatability survey. Data for the evaluation of taste of surufatinib oral suspension was summarized on a scale of 1 (very bad) through 5 (very nice). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT05093322/registered