Trial · NCT05395741
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 | EFS - (Event-Free Survival). | 1 year | To explore the efficacy in terms of EFS - (Event-Free Survival) |
| Primary | Determining the dose of the test substance in patients between 9 and 21 years of age, at which exposure to the drug will be similar to that recommended for adults. | 1 year | Safety will be assessed by the rate of participants presenting with Adverse Events stratified by grade, category, affected organ or system, as number of serious adverse events (SAEs) |
| Primary | Assessment of safety in terms of AEs | from date of randomization, until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months. | Safety will be assessed by the rate of participants presenting with Adverse Events stratified by grade, category, affected organ or system, as number of adverse events (AEs), including adverse events of special interest |
| Primary | Assessment of the safety of regorafenib | from date of randomization, until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months. | Safety will be assessed by analyzing recorded vital signs, laboratory test results, echocardiography, and ECG. |
| Secondary | PFS (Progression-Free Survival). | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | progression-free survival - will be measured from randomization to the detection of disease progression in imaging tests. |
| Secondary | OS (Overall Survival). | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | overall survival - will be measured from randomization to death due to cancer. |
| Secondary | ORR (Overall Response Rate). | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | the percentage of patients who achieved the response to treatment defined in the protocol. |
| Secondary | Time to achieving sufficient drug concentration in serum. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | Concentration parameters will come directly from the concentration values measured in PK samples. |
| Secondary | Maximum serum concentration in steady state Cmaxs. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | Concentration parameters will come directly from the concentration values measured in PK samples. |
| Secondary | Minimum serum concentration in steady state Cminss. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | Concentration parameters will come directly from the concentration values measured in PK samples. |
| Secondary | Random serum concentration in steady state Css. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | Concentration parameters will come directly from the concentration values measured in PK samples. |
| Secondary | Drug exposure Ctau. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | by monitoring the patient's clinical and molecular status |
| Secondary | Time to achieving steady state drug concentration in serum. | Safety analyzes are planned in accordance with the schedule of intermediate analyzes, at least every 12 months. | by monitoring the patient's clinical and molecular status |
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/NCT05395741/registered