Trial · NCT03909971
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Objective Response (Cohort 1) | From Cycle 1 Day 1 to documented progression of disease by ICR (up to 67 weeks) | Objective response rate (ORR) was defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 relative to the total participants in the analysis population. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR was defined as a greater than equal to (\>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Independent Central Radiology (ICR) was used for disease progression assessment. |
| Secondary | Percentage of Participants With Objective Response (Cohort 2) | From Cycle 1 Day 1 to documented progression of disease by ICR (up to 67 weeks) | ORR was defined as the percentage of participants with a best overall confirmed response of CR or PR according to RECIST version 1.1 relative to the total participants in the analysis population. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. ICR was used for disease progression assessment. |
| Secondary | Progression-Free Survival (PFS) Based on ICR Assessment | From first dose (Cycle 1 Day 1) to documented PD by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | PFS was defined as the time from first dose to first documentation of objective disease progression (PD) or to death due to any cause, whichever came first. PD: at least a \>=20 percent (%) increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, PD was defined as unequivocal progression of existing non-target lesions, or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. Analysis was performed using Kaplan Meier method. ICR was used for disease progression assessment. |
| Secondary | Progression-Free Survival Based on Investigator Assessment | From first dose (Cycle 1 Day 1) to documented progression of disease by investigator, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | PFS was defined as the time from first dose to first documentation of objective PD or to death due to any cause, whichever came first. PD: at least a \>=20 % increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, PD was defined as unequivocal progression of existing non-target lesions, or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. Analysis was performed using Kaplan Meier method. Investigator assessment was used for disease progression assessment. |
| Secondary | Overall Survival | From first dose (Cycle 1 Day 1) to date of death due to any cause (up to 271 weeks of treatment exposure) | Overall survival was defined as the time from first dose to the date of death due to any cause. Analysis was performed using Kaplan Meier method. |
| Secondary | Percentage of Participants With Intracranial Objective Response (IC-OR) Based on ICR Assessment | From first dose (Cycle 1 Day 1) to documented PD by ICR (up to 271 weeks of treatment exposure) | IC-OR: percentage of participants with a best overall confirmed intracranial response of CR or PR according to RECIST version 1.1 relative to total participants in the analysis population but limited to intra cranial lesions only in participants with central nervous system metastases. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>= 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. 95% CI was based on Clopper-Pearson method. |
| Secondary | Percentage of Participants With Intracranial Objective Response Based on Investigator Assessment | From first dose (Cycle 1 Day 1) to documented progression of disease by investigator (up to 271 weeks of treatment exposure) | IC-OR: percentage of participants with a best overall confirmed intracranial response of CR or PR according to RECIST version 1.1 relative to total participants in the analysis population but limited to intra cranial lesions only in participants with central nervous system metastases. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>= 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. 95% CI was based on Clopper-Pearson method |
| Secondary | Duration of Response (DOR) Based on ICR Assessment | From first documentation of CR or PR to documented progression of disease by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | DOR: time from first documentation of CR or PR to first documentation of PD or death due to any cause, whichever occurred first. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10mm. PR:\>=30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. PD:\>=20 % increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since treatment started, or the appearance of one or more new lesions. In addition to relative increase of 20% sum must also demonstrate an absolute increase of at least 5 mm and for non-target lesions PD: unequivocal progression of existing non-target lesions or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at time of analysis were censored at date of last tumor assessment. Analysis was performed using Kaplan Meier method. |
| Secondary | DOR Based on Investigator Assessment | From first documentation of CR or PR to documented PD by investigator, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure | DOR: time from first documentation of CR or PR to first documentation of PD or death due to any cause, whichever occurred first. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes must have reduction in short axis to \<10mm. PR:\>=30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. PD:\>=20 % increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since treatment started, or the appearance of one or more new lesions. In addition to relative increase of 20% sum must also demonstrate an absolute increase of at least 5 mm and for non-target lesions PD: unequivocal progression of existing non-target lesions or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at time of analysis were censored at date of last tumor assessment. Analysis was performed using Kaplan Meier method. |
| Secondary | Duration of Intracranial Response Based on ICR Assessment | From first documentation of CR or PR to documented progression of disease by ICR, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | Duration of intracranial response: time from first documentation of CR or PR considering only lesions having disease site=brain to first documentation of PD or death due to any cause, whichever occurred first, participants who had at least 1 intracranial lesion.CR: disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in \<10mm.PR:\>=30% decrease in the sum of the longest dimensions of target lesions taking reference the baseline sum longest dimension. PD:\>=20% increase in sum of longest dimensions of target lesion, or appearance of one or more new lesion. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5mm and for non-target lesion PD: unequivocal progression of existing non-target lesion, or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. Kaplan Meier method was used. |
| Secondary | Duration of Intracranial Response Based on Investigator Assessment | From first documentation of CR or PR to documented progression of disease by investigator, death due to any cause or date of censoring, whichever occurred first (up to 271 weeks of treatment exposure) | Duration of intracranial response: time from first documentation of CR or PR considering only lesions having disease site=brain to first documentation of PD or death due to any cause, whichever occurred first, participants who had at least 1 intracranial lesion.CR: disappearance of all target and non-target lesions. Any pathological lymph nodes must have reduction in \<10mm.PR:\>=30% decrease in the sum of the longest dimensions of target lesions taking reference the baseline sum longest dimension. PD:\>=20% increase in sum of longest dimensions of target lesion or appearance of one or more new lesion. In addition to relative increase of 20% sum must also demonstrate an absolute increase of at least 5mm and for non-target lesion PD: unequivocal progression of existing non-target lesion, or the appearance of \>=1 new lesion. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. Kaplan Meier method was used. |
| Secondary | Time to Tumor Response Based on ICR Assessment | From first dose (Cycle 1 Day 1) to first documented CR or PR (up to 271 weeks of treatment exposure) | Time to tumor response was defined as the time from first dose to first documentation of objective tumor response CR or PR. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Secondary | Time to Tumor Response Based on Investigator Assessment | From first dose (Cycle 1 Day 1) to documented first CR or PR (up to 271 weeks of treatment exposure) | Time to tumor response was defined as the time from first dose to first documentation of objective tumor response CR or PR. CR was defined as the disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. |
| Secondary | Number of Participants With Adverse Events (AEs) | From start of study treatment (Cycle 1 Day 1) up to 28 days after the last administration of the investigational product, up to approximately 275 weeks | AE:any untoward medical occurrence in a study participant administered a product or medical device;event did not necessarily have a causal relationship with treatment or usage.Serious AE:any untoward medical occurrence at any dose resulted in death;life-threatening;required inpatient or prolongation of existing hospitalization;persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important event.AEs were graded by the National Cancer Institute Common Terminology Criteria AE(NCICTCAE)v4.03 where,Grade(G)1:mild AE;G2:moderate;G3:severe;G4:life-threatening consequences,urgent intervention indicated;G5:death related to AE. Focus of AE summaries was on treatment-emergent AE(TEAE).AE was considered TEAE if the event occurred during the on-treatment period.On-treatment:time from first dose of study treatment through end of study follow-up(i.e.,up to 28 days after last dose of treatment. Participant with G3or4 and5 AEs were reported. |
| Secondary | Number of Participants With Central Nervous System-Related Adverse Events | From start of study treatment (Cycle 1 Day 1) up to 28 days after the last administration of the investigational product, up to approximately 275 weeks | An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event did not necessarily have a causal relationship with the treatment or usage. The central-nervous system-related AEs included AEs under the cluster terms of mood effects, cognitive effects, psychotic effects, and speech effects. |
| Secondary | Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | From start of study treatment (Cycle 1 Day 1) up to 28 days after the last administration of the investigational product, up to approximately 275 weeks | Laboratory tests included hematology, chemistry and lipids. Laboratory test results were graded according to NCI CTCAE version 4.03, where Grade 0: no AE, Grade 1 : mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Shifts from Grade \<=2 at baseline to Grade 3 or 4 post-baseline were considered clinically significant. Only categories with non-zero values were reported in this outcome measure. |
| Secondary | Number of Participants With Vital Signs Data Meeting Pre-specified Criteria | From start of study treatment (Cycle 1 Day 1) up to 28 days after the last administration of the investigational product, up to approximately 275 weeks | Vital signs evaluation included diastolic blood pressure (DBP), systolic blood pressure (SBP), pulse rate and weight. Blood pressure and pulse rate were recorded in sitting position after the participant had been sitting quietly for at least 5 minutes. The pre-specified criteria included: sitting SBP change \>=40 millimeters of mercury (mmHg) increase, \>=40 mmHg decrease; sitting DBP change \>=20 mmHg increase, change \>=20 mmHg decrease, or change \>=60 mmHg increase; sitting pulse rate value \<50 beats per minute (bpm), \>120 bpm, change \>=30 bpm increase, or change \>=30 bpm decrease; weight 10% \<= change \<20% increase, change \>=20% increase or change \>=10% decrease. One participant can have more than one vital sign data meeting pre-specified criteria. |
| Secondary | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria | From start of study treatment (Cycle 1 Day 1) up to 28 days after the last administration of the investigational product, up to approximately 275 weeks | The QT intervals were corrected for heart rate (QTc) using standard correction factors (ie, QTcF \[Fridericia's\], QTcB \[Bazett's\], and possibly a study-specified factor, as appropriate). The pre-specified criteria included: PR interval change \>= 50% and baseline \<200 msec, change \>=25% and baseline \>=200 msec; QRS interval change \>=50% and baseline \<100 msec, change \>=25% and baseline \>=100 msec; QTcB values \<=450 msec, 450 \< Value \<= 480 msec, 480 \< Value \<= 500 msec, value \>500 msec, change \<=30 msec, 30 \< Change \<= 60 msec, change \>60 msec; QTcF value \<=450 msec, 450 \< Value \<= 480 msec, 480 \< Value \<= 500 msec, Value \> 500 msec, change \<=30 msec, 30 \< Change \<=60 msec and change \>60 msec. . One participant can have more than one ECG data meeting pre-specified criteria. |
| Secondary | Number of Participants With Left Ventricular Ejection Fraction (LVEF) Meeting Pre-specified Criteria | From start of study treatment (Cycle 1 Day 1) up to 28 days after the last administration of the investigational product, up to approximately 275 weeks | Echocardiogram or multigated acquisition scan were performed to monitor LVEF. Pre-specified criteria included shift from baseline normal to post-baseline below lower limit of normal (LLN) \>=20-point decrease from baseline in LVEF% . |
| Secondary | Cycle 1 Day 1 Maximum Plasma Concentration (Cmax) | At pre-dose, 0.5, 1, 2, 3, 4, 6 ,8, 9 and 24 hours on Cycle 1 Day 1 | The loratinib Cmax was estimated using non-compartmental analysis. |
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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