Trial · NCT02150967
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR) | Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Percentage (%) of subjects with CR or PR | NUMBER |
| SECONDARY | Overall Response Rate (ORR) as Assessed by the Investigator | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff for the primary analysis was 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Percentage (%) of subjects with CR or PR | NUMBER |
| SECONDARY | Best Overall Response (BOR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate (DCR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | Percentage (%) with CR, PR, or SD | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35). | months | MEDIAN |
| SECONDARY | Response Onset | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were confirmed responders (CR or PR) as assessed by BICR (N = 25) or by the Investigator (N = 35). | months | MEDIAN |
| OTHER_PRE_SPECIFIED | Growth Modulation Index (GMI) | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects with both a PFS measure while on infigratinib and available TTP for their last prior line of therapy (N = 103). | Ratio (PFS/TTP) in Months | MEDIAN |
| POST_HOC | Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on ORR | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N = 59). | Percentage (%) of patients with CR or PR | NUMBER |
| POST_HOC | Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on PFS | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib. Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59). | months | MEDIAN |
| POST_HOC | Retrospective Analysis of Post-second-line Antineoplastic Treatment Outcomes on BOR | Analysis conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021. | Full Analysis Set (FAS), defined as all subjects in Cohort 1 who had received at least one dose of infigratinib Conducted in a subgroup of subjects who were receiving infigratinib as a third or later line of treatment (N=59). | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT02150967/outcomes