Trial · NCT01874665
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 | Clinical Benefit Rate (CBR) in Cohort A | 16 weeks after first dose | To assess clinical benefit rate in participants with KIT exon 11-mutant GIST.It is defined as the composite of complete response(CR),partial response(PR),and stable disease(SD) lasting \>=16 weeks per modified Response Evaluation Criteria In Solid Tumors(RECIST) 1.1 as a measure of disease control.CR is complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.All nodes, both target and non-target, must decrease to normal (short axis \<10millimeter \[mm\]).No new lesions.PR is \>=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD is not qualifying for CR,PR,Progressive Disease(PD).PD is \>=20% increase from the smallest prior sum of the longest diameter(SLD)and with \>=5mm absolute increase, or appearance of a new lesion. |
| Secondary | Clinical Benefit Rate (CBR) in Cohort B | 16 weeks after first dose | To assess clinical benefit rate in participants with GIST that lacks KIT exon 11 mutations (Cohort B) and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 millimeter \[mm\]). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as not qualifying for CR, PR, PD. |
| Secondary | Progression-free Survival (PFS) | From date of enrollment until the end of the study or disease progression or death due to any cause, whichever came first, assessed up to 3 years | PFS is defined as the duration of time from start of study drug administration to time of objective disease progression or death due to any cause, whichever may come first. To assess PFS in each cohort and in the total participant population. |
| Secondary | Percentage of Participants With Objective Response Rate (ORR) | From date of enrollment until discontinuation or the end of the study, whichever came first, assessed up to 3 years | ORR is defined as the composite of CR and PR per Response Evaluation Criteria in RECIST 1.1, assessed for each cohort and in the total participant population. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. |
| Secondary | Overall Survival (OS) | From first dose of drug until the end of the study or death, whichever came first, assessed up to 3 years | OS is defined as the time interval between the first dose of study drug to death due to any cause. Overall survival was analyzed using the Kaplan-Meier method. |
| Secondary | Number of Participants With Physical Examination | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Sign Measurements | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With Worst Shift From Baseline Values to Post-baseline Values in Laboratory Parameters | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With TEAEs Related to Electrocardiogram (ECG) Findings | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants With TEAEs Related to Echocardiography Parameter | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Number of Participants Reporting One or More TEAEs and Serious Adverse Event (SAE) | From date of enrollment until the End-of-Treatment, assessed up to 3 years | |
| Secondary | Cmax, SS: Maximum Observed Plasma Concentration at Steady State for Ponatinib | Pre-dose and at multiple timepoints (up to 1 month) post-dose |
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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