Trial · NCT02867592
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 | Objective Response (Non-Osteosarcoma Strata) | Up to the first 6 cycles of therapy | Will be assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Response rates will be calculated as the percent of evaluable patients who are responders (Overall Best Response of Partial Response or Complete Response), and confidence intervals will be constructed accounting for the two-stage design. |
| Primary | Objective Response (Osteosarcoma Stratum) | Up to the first 6 cycles of therapy. | Will be assessed by the Response Evaluation Criteria in Solid Tumors version 1.1 and Disease Control (see section 9.3.2 of the ADVL1622 Protocol). Response + Disease Control rate will be calculated as the percent of evaluable patients who are responders or who met the definition of disease control, and confidence intervals will be constructed accounting for the two-stage design. |
| Secondary | Percentage of Participants With Adverse Events | Up to 5 years (duration of protocol therapy plus 30 days after last dose of therapy) | Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will report the percentage of patients within each disease stratum who experienced a grade 3 or higher toxicity with attribution of possible, probable, or definite while on protocol therapy or within 30 days of the last dose of therapy |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Cmax | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | Day 1 PK peak concentration will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Tmax | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | Day 1 PK time to peak concentration will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: AUC | Prior to dose, 2, 4, 8 and 20-28 hours after dose on day 1 | Day 1 PK area under the curve will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Accumulation | Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22 | PK accumulation will be summarized by the mean and the standard deviation. |
| Secondary | Pharmacokinetics (PK) Parameters of Cabozantinib S-malate: Half-life | Cycle 1, Day 1 (20-28 hours after dose) and Cycle 1, Day 22 | PK half-life will be summarized by the mean and the standard deviation. |
| Secondary | Time to Progression (TTP) | Up to 1 year | Percent of patients not yet progressed at 1 year as estimated by the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), 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. Clinical progression was also counted as an event for this analysis. |
| Secondary | Progression Free Survival (PFS) | Up to 1 year | The 1-year Progression Free Survival will be estimated using Kaplan-Meier methodology. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.1), 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 |
| Secondary | Overall Survival (OS) | Up to 1 year | The 1-year Overall Survival will be estimated using Kaplan-Meier methodology. |
| Other | Change in Immune Biomarkers | Baseline, day 1 (prior to dose) of cycles 2 and 3 | The association between the host immune system and response to cabozantinib-s-malate will be assessed in an exploratory manner. each biomarker will be correlated with the clinical outcomes of objective response and progression free survival. |
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/NCT02867592/registered