Trial · NCT07146646
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease control rate (DCR) by RECIST v1.1 | Every 8 weeks until treatment discontinuation, up to 6 months | DCR is the percentage of participants whose cancer did not get worse after treatment (i.e. the percentage of participants who had CR, PR, or SD, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Safety and tolerability | Day 1 | Measured by the grade of adverse events (AEs) per CTCAE version 5.0 |
| Secondary | Safety and tolerability | At treatment discontinuation, up to 6 months | Measured by the grade of adverse events (AEs) per CTCAE version 5.0 |
| Secondary | Safety and tolerability | 30 days post-study treatment discontinuation, up to 6 months | Measured by the grade of adverse events (AEs) per CTCAE version 5.0 |
| Secondary | Safety and tolerability | Day 1 | Measured by the incidence of adverse events (AEs) |
| Secondary | Safety and tolerability | At treatment discontinuation, up to 6 months | Measured by the incidence of adverse events (AEs) |
| Secondary | Safety and tolerability | 30 days post-study treatment discontinuation, up to 6 months | Measured by the incidence of adverse events (AEs) |
| Secondary | Safety and tolerability | Day 1 | Measured by the duration of adverse events (AEs) |
| Secondary | Safety and tolerability | At treatment discontinuation, up to 6 months | Measured by the duration of adverse events (AEs) |
| Secondary | Safety and tolerability | 30 days post-study treatment discontinuation, up to 6 months | Measured by the duration of adverse events (AEs) |
| Secondary | Objective response rate (ORR) by RECIST v1.1 | Every 8 weeks until treatment discontinuation, up to 6 months | ORR is the percentage of participants whose cancer got better after treatment (i.e. the percentage of participants who had CR or PR, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Progression free survival (PFS) | 2 years post-study treatment | Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. |
| Secondary | Overall survival (OS) | 2 years post-study treatment | Overall survival (OS) is defined as the duration of time from start of treatment to time of death from any cause. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07146646/registered