Trial · NCT02606461
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 3 Double Blind: Progression-free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 | From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) | PFS was defined as the time from the date of randomization until the first date of Independent Review Committee (IRC)-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the sum of the longest diameter (SLD), taking as reference the smallest sum of the longest diameter (SLD) recorded from baseline or the appearance of 1 or more new lesions. |
| Primary | Phase 3 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From the date of randomization in the Phase 3 open label period until the first date of disease progression, or death due to any cause whichever occurred first (up to 57 months) | PFS was defined as the time from the date of randomization in the Phase 3 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Primary | Phase 2 Double Blind: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) | PFS was defined as the time from date of randomization until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Primary | Phase 2 Open Label: Progression-free Survival (PFS) as Per RECIST Version 1.1 | From date of randomization in the Phase 2 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 57 months) | PFS was defined as the time from date of randomization in the Phase 2 open-label period until the first date of IRC-confirmed PD per RECIST version 1.1, or death due to any cause. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 3 Double Blind: Overall Survival (OS) | From date of randomization until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 3 Open Label: Overall Survival (OS) | From date of randomization in phase 3 open label period until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization in the Phase 3 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 2 Double Blind: Overall Survival (OS) | From the date of randomization until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 2 Open Label: Overall Survival (OS) | From date of randomization in the Phase 2 open-label period until death due to any cause, whichever occurred first (up to 70 months) | OS was defined as the duration (in months) from the date of randomization in the Phase 2 open-label period to death from any cause. Participants last known to be alive were censored at the date of discontinuation from the study, or database cut date, whichever was earlier. |
| Secondary | Phase 3 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | TTP was defined as the time from date of randomization until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 3 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization in the Phase 3 open label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | TTP was defined as the time from date of randomization in the Phase 3 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 2 Double Blind: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | TTP was defined as the time from date of randomization until ICR-determined PD as per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 2 Open Label: Time-to-Progression (TTP) as Per RECIST Version 1.1 | From date of randomization in the Phase 2 open-label period until the first date of PD or death due to any cause, whichever occurred first (up to 70 months) | TTP was defined as the time from date of randomization in the Phase 2 open-label period until ICR-determined PD per RECIST version 1.1, or death due to disease progression, whichever occurred first. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 3 Double Blind: Overall Response Rate (ORR) | From date of randomization until the documentation of CR or PR (up to 70 months) | ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR), per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 3 Open Label: Overall Response Rate (ORR) | From date of randomization in the Phase 3 open label period until the documentation of CR or PR (up to 70 months) | ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 2 Double Blind: Overall Response Rate (ORR) | From date of randomization until the documentation of CR or PR (up to 70 months) | ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 2 Open Label: Overall Response Rate (ORR) | From date of randomization in the Phase 2 open-label period until the documentation of CR or PR (up to 70 months) | ORR was defined as the percentage of participants who achieved CR or PR, per RECIST v.1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Phase 3 Double Blind: Duration of Response (DOR) | From first occurrence of CR or PR until the first date of PD (up to 70 months) | DOR was defined as the time from first occurrence of CR or PR until the first date of PD per RECIST version 1.1 or death. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 3 Double Blind: Progression-free Survival (PFS) as Per Investigator Assessment | From the date of randomization until the first date of disease progression, or death due to any cause whichever occurred first (up to 70 months) | PFS was defined as the time from date of randomization until the first date of PD, per RECIST version 1.1, or death due to any cause as defined by the Investigator based on clinical and/or radiologic criteria. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. |
| Secondary | Phase 3 Double Blind: Time to Next Treatment (TTNT) | Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months) | TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first. |
| Secondary | Phase 2 Double Blind: Time to Next Treatment (TTNT) | Time from randomization to the first new antineoplastic therapy or death due to any cause (up to 70 months) | TTNT was defined as time since randomization until the first new antineoplastic therapy or death due to any cause, whichever occurs first. |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02606461/registered