Trial · NCT05520723
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 | Incidence of grade ≥2 diarrhea | Baseline up to end of 2nd cycle (day 42) | The rate of patients with grade ≥ 2 diarrhea is defined as the number of patients with diarrhea grade 2 to 5 the first 2 cycles of treatment by the number of patients in the analysis set per 100. The adverse events will be assessed by the Investigator and with severity determined using defined and graded according CTCAE v.5.0. The adverse events without the severity grade reported will be considered as grade 3. |
| Primary | Incidence of grade ≥3 neutropenia | Baseline up to end of 2nd cycle (day 42) | The rate of patients with grade ≥ 3 neutropenia is defined as the number of patients with neutropenia grade 3 to 5 the first 2 cycles of treatment by the number of patients in the analysis set per 100. The adverse events will be assessed by the Investigator and with severity determined using defined and graded according CTCAE v.5.0. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Incidence of all grades and grade ≥3 diarrhea. | Until EoS (26 months after study initiation) | Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Incidence of all grades and grade ≥3 neutropenia. | Until EoS (26 months after study initiation) | Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Incidence of febrile neutropenia and additional adverse events (AEs) as per NCI-CTCAE v.5.0. | Until EoS (26 months after study initiation) | Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Discontinuation rate | Until EoS (26 months after study initiation) | The discontinuation rate is defined as the proportion of participants discontinued to any cause relative to the number of patients in the analysis set. The reasons for study discontinuation and the period from the treatment initiation to the time of discontinuation will be also reported. |
| Secondary | Dose reduction rate | Until EoS (26 months after study initiation) | The dose reduction rate is defined as the proportion of participants with dose reduction relative to the number of patients in the analysis set. The reasons for dose reduction and the period from the treatment initiation to the time of the first dose reduction will be also reported. |
| Secondary | Objective response rate (ORR) | Until EoS (26 months after study initiation) | Objective response rate is defined as the proportion of participants with complete response or partial response relative to the number of patients in the analysis set. It will be also calculated only for patients with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response will be counted as non-responders in the assessment of ORR. Tumor response will be defined as best response based on local investigator's assessment according to RECIST v1.1. |
| Secondary | Clinical benefit rate (CBR) | Until EoS (26 months after study initiation) | Clinical benefit rate is defined as the proportion of participants with objective response, or stable disease ≥24 weeks relative to the number of patients in the analysis set. Non-complete response/non-progressive disease will be considered as stable disease. Clinical benefit will be also calculated only for patients with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response, or stable disease ≥24 weeks will be counted as without clinical benefit. Tumor response will be defined as best response based on local investigator's assessment according to RECIST v1.1 (Appendix 2). |
| Secondary | Duration of response (DoR) | Until EoS (26 months after study initiation) | Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of disease progression, death due to any cause or treatment discontinuation, whichever occurs first. Duration of response will be calculated in patients with objective response as \[the date response ended (i.e., date of PD, death or discontinuation) - first objective response date +1)\]/30.4. |
| Secondary | Time to response (TtR) | Until EoS (26 months after study initiation) | Time to response is defined as the period from the treatment initiation to time of the first objective tumor response (tumor shrinkage of ≥30%) observed for patients who achieved an objective response, as determined locally by the investigator through the use of RECIST v.1.1. The length of time to response will be calculated in patients with objective response as \[(Objective response or censor date) - treatment initiation date +1\]/30.4. |
| Secondary | Best percentage of change from baseline in the size of target tumor lesions. | Until EoS (26 months after study initiation) | Best percentage of change from baseline in the size of target tumor lesions, defined as the biggest decrease, or smallest increase if no decrease will be observed, as determined locally by the investigator using RECIST v.1.1. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response, or stable disease ≥24 weeks will be counted as not available. The analysis will be performed on patients with measurable disease at baseline. |
| Secondary | Progression free survival (PFS) | Until EoS (26 months after study initiation) | Progression-free survival is defined as the period from the date of treatment initiation to the date of the first documentation of objective progressive disease determined locally by investigator or death due to any cause in absence of documented progressive disease. Participants lacking an evaluation of tumor response after treatment initiation will have their progression-free survival time censored on the date of treatment initiation with the duration of a day. The length of progression-free survival will be calculated as \[(progression, death date or censor date) - treatment initiation date +1\]/30.4. Progression will be determined locally by the investigator using RECIST v.1.1. Objective PD is defined as 20% increase in the sum of diameters of target lesions above the smallest sum observed. The sum must also demonstrate and absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions or the appearance of new lesion. |
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/NCT05520723/registered