Trial · NCT04322539
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From date of randomization to death from any cause (up to 22 months) | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS), as Assessed by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 | From randomization until the first documentation of objective progression or death, whichever comes first (up to 22 months) | ITT population included all randomized participants. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | From randomization until the first documentation of best overall response (up to 22 months) | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | From randomization until the first documentation of best overall response (up to 22 months) | ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | From first occurrence of PR or CR until the first documentation progression or death, whichever comes first (up to 22 months | Analysis was performed on subset of participants who had a response. Here, '0' in 'overall number of participants analyzed represents that DOR could only be analyzed in participants who achieved a response. As no participant in the Placebo Plus BSC Group cohort achieved any response, no DOR is available. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration up to approximately 40 months | SP included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Observed Plasma Concentrations of Fruquintinib and Metabolite M11 | Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 (Day 21): Predose and 2 hours, Cycle 3 (Day 1): Pre-dose, Cycle 3 (Day 21): Pre-dose and 2 hours, Cycle 5, 7, 9, 11, 13, 15 and 17 (Day 1): Pre-dose (Each cycle = 28 days) | PK population was used for tabulation of fruquintinib and M11 concentrations from PK plasma samples collected from the Fruquintinib + BSC Group. PK samples for the Placebo + BSC Group were not analyzed. Here, Overall Number of Participants Analyzed signifies those participants in the Fruquintinib + BSC Group who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified timepoints. | nanogram/milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline of Electrocardiogram (ECG) Results - QTcF Intervals Using Fridericia's Formula | Baseline, Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 and 3 (Day 21): Pre-dose (Each cycle = 28 days) | SP included all randomized participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at the specified time points. | millisecond (msec) | MEAN |
| SECONDARY | Change From Baseline of ECG Results -QTcB Intervals Using Bazzett's Formula | Baseline, Cycle 1 (Day 1 and 21): Pre-dose, 1, 2, 3 and 4 hours; Cycle 2 and 3 (Day 21): Pre-dose (Each cycle = 28 days) | SP included all randomized participants who received at least 1 dose of study drug. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable at the specified timepoints. | msec | MEAN |
| SECONDARY | Correlation Between Fruquintinib Exposure (CminSS) and Efficacy Parameters (OS) | Up to 22 months | The efficacy exposure-response analyses included participants who were evaluable for the population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for the parameter/endpoint in question. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. The population for this measure included participants from both studies 2015-013-00US1 and the current study. | 1/(ng/mL) | NUMBER |
| SECONDARY | Correlation Between Fruquintinib Exposure (CmaxSS) and Safety Parameters (Any Grade [Gr] and Grade 3+ (Gr3+): Dermatological Toxicity, Proteinuria and Gr Hemorrhage) | Up to 22 months | Safety exposure-response analyses included participants who were evaluable for population PK analysis and therefore had PK parameter estimates to enable estimation of fruquintinib exposure and evaluated for parameter/endpoint in question. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. The population for this measure included participants from 2019-013-GLOB1, 2009-013-00CH1, 2012-013-00CH3, and 2015-013-00US1. | 1/(ng/mL) | NUMBER |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life (QOL) Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale Score | Baseline, Cycle 2, 3 and 4 (Each cycle=28 days) | ITT population included all randomized participants. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable at the specified timepoints. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score | Baseline, Cycle 2, 3 and 4 (Each cycle=28 days) | ITT population included all randomized participants. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable at the specified categories. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Health Utility Index Scores | Baseline, Cycle 2, 3 and 4 (Each cycle=28 days) | ITT population included all randomized participants. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable at the specified categories. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Health Care Resource Utilization: Duration of Hospital Visits by Participants | From start of study drug administration up to 22 months | ITT population included all randomized participants. | days per visit | MEAN |
| SECONDARY | Health Care Resource Utilization: Number of Participants With Any Concomitant Medications Prescribed | From start of study drug administration up to 22 months | ITT population included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
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.
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