Trial · NCT03790111
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment | Month 6 | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate. |
| Primary | Project Overall Survival Rate at Month 6 | 6 Months | Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6. |
| Secondary | Overall Survival (OS) | First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months | Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause. |
| Secondary | Project Overall Survival Rate at Month 12 | 12 Months | Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12. |
| Secondary | Median Progression Free Survival | Month 12 | Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. |
| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | Month 6 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.". |
| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | Month 12 | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. |
| Secondary | Disease Control Rate (DCR), Central Radiologist's Assessment | End of Study up to 24 months | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. |
| Secondary | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Month 6 | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (CR) + partial response (PR) at Months 6 |
| Secondary | Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | Month 12 | Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12. |
| Secondary | Overall (Objective) Response Rate, Central Radiologist's Assessment | End of Study as defined up to 24 months | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. |
| Secondary | Summary of Duration of Progression Free Survival, Local Radiologist's Assessment | up to 7 months | Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months. |
| Secondary | Progression Free Survival, Local Radiologist's Assessment | Month 12 | Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12. |
| Secondary | Progression Free Survival, Local Radiologist's Assessment | End of Study as defined up to 24 months | Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study |
| Secondary | Overall (Objective) Response Rate, Local Read | 6 Months | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6. |
| Secondary | Overall (Objective) Response Rate, Local Reader's Assessment | 12 Months | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12. |
| Secondary | Overall (Objective) Response Rate (ORR), Local Reader's Assessment | End of Study as defined up to 24 months | Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. |
| Secondary | Disease Control Rate (DCR), Local Reviewer | Month 12 as defined by 1 year | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. |
| Secondary | Disease Control Rate (DCR), Local Reviewer | Month 6 | Disease control rate (DCR), Local Reviewer, 6 Months |
| Secondary | Disease Control Rate End of Study, Local Reviewer | End of Study as defined up to 24 months | Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR. |
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.
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GET https://conductscience.org/api/trials/v1/NCT03790111/registered