Trial · NCT07367178
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the incidence and severity of diarrhea during the first two treatment cycles | Baseline up to end of 2nd cycle (day 42) | Incidence of grade ≥2 diarrhea during the first two treatment cycles as assessed by the Investigator, with severity determined by the NCI-CTCAE v.6.0. |
| Secondary | To assess the incidence and severity of constipation during the first two treatment cycles | Baseline up to end of 2nd cycle (day 42) | Incidence of all grades constipation during the first two treatment cycles, as assessed by the Investigator, with severity determined by the NCI-CTCAE v.6.0. |
| Secondary | To determine the overall safety profile during the first two treatment cycles and the extended follow-up. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Overall safety profile according to the NCI-CTCAE v.6.0 during the first two treatment cycles and the extended follow-up |
| Secondary | To evaluate the incidence and severity of diarrhea during the first two treatment cycles versus extended follow-up. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Incidence of all grades diarrhea during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.6.0. |
| Secondary | To evaluate the incidence and severity of constipation during the first two treatment cycles versus extended follow-up. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Incidence of all grades constipation during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.6.0. |
| Secondary | To assess the dose reduction rate. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Dose reduction rate, defined as the proportion of participants with dose reduction due to toxicity relative to the number of participants in the analysis set. |
| Secondary | To evaluate the dose interruption rate. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Dose interruption rate, defined as the proportion of participants with dose interruption due to toxicity relative to the number of participants in the analysis set. |
| Secondary | To analyze the discontinuation rate. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Discontinuation rate, defined as the proportion of participants who discontinued Study treatment to any cause relative to the number of participants in the analysis set. |
| Secondary | To assess real-world progression-free survival (rwPFS). | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | rwPFS, defined as the time between start of treatment to date of disease progression or death documented in participant medical charts, whichever date came first. |
| Secondary | To evaluate the time to treatment failure (TTF). | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | TTF, defined as the time from the start of treatment to its discontinuation for any reason, including disease progression, treatment-related toxicity, participant withdrawal, or death. |
| Secondary | To determine the time to treatment failure due to toxicity (TTF-Toxicity). | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | TTF-Toxicity, defined as the time from the start of treatment to its discontinuation especially due to treatment-related adverse events (TEAEs). It excludes discontinuation for other reasons such as disease progression, participant withdrawal, or death unrelated to toxicity. |
| Secondary | To assess overall survival (OS). | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | OS, defined as the period from treatment initiation to death from any cause, as determined locally by the Investigator. |
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/NCT07367178/registered